Home: Clinical Trials: Finding Clinical Trials
Europe
AUSTRIA: WIEN
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
BELGIUM
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
ENGLAND
Phase III Randomized Study of Ultraviolet A Light Therapy with Methoxsalen (PUVA) with or without Bexarotene in Patients with Mycosis Fungoides
OBJECTIVE: Compare the cumulative dose of ultraviolet A light required to achieve a complete clinic response (CCR) and overall response rate (complete or partial) in patients with mycosis fungoides treated with ultraviolet A light therapy with PUVA with or without bexarotene.
ELIGIBILITY REQUIREMENTS: Histologically confirmed mycosis fungoides Stage IB or IIA. Age over 18. Not pregnant of nursing. Willing and able to avoid prolonged exposure to the sun. No prior intolerance of or unresponsiveness to PUVA therapy. No other concurrent serious illness or infection. No uncontrolled diabetes mellitus or uncontrolled thyroid disease.
CONTACT INFORMATION:
EORTC Cutaneous Lymphoma Task Force
ST. John’s Institute of Dermatology
Sean Whittaker MD PH: 44-20-792-892-92 ext. 1333
London, ENGLAND
DENMARK
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
PURPOSE
The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion criteria include:
• A histologically confirmed diagnosis of PTCL
• Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen.
Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
• Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).
• Age ≥ 18 years.
• Adequate bone marrow, liver, and renal functions.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Negative pregnancy test for women of childbearing potential.
Exclusion criteria include:
• Relapse within 100 days of autologous or allogeneic bone marrow transplant.
• Prior HDAC inhibitor therapy.
• Co-existing active infection or any medical condition likely to interfere with trial procedures.
• Severe cardiovascular disease.
• Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
• Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
• Symptomatic or untreated central nervous system (CNS) metastases.
• Pregnant or breast-feeding women.
• Known infection with HIV, hepatitis B or hepatitis C.
CONTACT
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865969
H:S Rigshospitalet, The Finsen Centre, KAT, Haematology Department 4241
Copenhagen, Denmark, 2100
Contact: Peter Brown, MD
+45 35 45 11 28
peter.brown@rh.regionh.dk
Principal Investigator: Peter Brown, MD
FINLAND
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
FINLAND: HELSINKI
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
FRANCE: PARIS, NICE, PIERRE BENITE, LYON
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
215-279-3015
CTCL@tenxbiopharma.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
FRANCE: CRETEIL, PESSAC, TOULOUSE and MONTPELLIER
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
FRANCE
Phase I/II Randomized Study of Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) With Versus Without Etoposide in Older Patients With Diffuse Large B-Cell or Peripheral T-Cell Non-Hodgkin’s Lymphoma
OBJECTIVE: Compare the complete response rates and overall survival in older patients with diffuse large B-cell or peripheral T-cell non-Hodgkin’s lymphoma treated with CHOP with vs without etoposide.
ELEGIBILITY REQUIREMENTS: Diagnosis of diffuse large B-cell or peripheral T-cell non-Hodgkin’s lymphoma. Age 70 and over. No history of concurrent severe disease or other concurrent use of antineoplastic agents.
CONTACT INFORMATION:
EORTC Lymphoma Group
Pierre Soubeyran MD PH: 33-5-56-33-32-67
Soubeyran_p@bergonie.org
Bordeaux, FRANCE
8am to 5pm EST
FRANCE
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
Hopital de l'Hotel-Dieu
Nantes, France, 44093
Contact: Brigitte DRENO, M.D. +33-240-083-116 brigitte.dreno@wanadoo.fr
Principal Investigator: Brigitte DRENO, M.D.
Hopital Lapeyronie
Montpellier, France, 34295
Contact: Jean François ROSSI, M.D. +33-467-338-079 jf-rossi@chu-montpellier.fr
Principal Investigator: Jean François ROSSI, M.D.
Hopital Henri Mondor
Créteil, France, 94010
Contact: Martine BAGOT, M.D. +33-149-812-501 martine.bagot@hmn.aphp.fr
Principal Investigator: Martine BAGOT, M.D.
FRANCE
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
GERMANY: BERLIN, KIEL, ESSEN, WURZBURG, MINDEN
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
215-279-3015
CTCL@tenxbiopharma.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
GERMANY
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
HUNGARY
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
ITALY
Belinostat in Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL)
PURPOSE
The purpose of this study is to assess efficacy and safety of belinostat in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), who failed at least one prior systemic therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion criteria include:
• A histologically confirmed diagnosis of PTCL
• Patients must have relapsed or refractory disease after at least one prior systemic anticancer regimen.
Systemic anticancer therapy is defined as chemotherapy or immunotherapy administered systemically.
• Patients must have at least one site of disease measurable in two dimensions by computed tomography (CT).
• Age ≥ 18 years.
• Adequate bone marrow, liver, and renal functions.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
• Negative pregnancy test for women of childbearing potential.
Exclusion criteria include:
• Relapse within 100 days of autologous or allogeneic bone marrow transplant.
• Prior HDAC inhibitor therapy.
• Co-existing active infection or any medical condition likely to interfere with trial procedures.
• Severe cardiovascular disease.
• Clinically significant central nervous system disorders with altered mental status or psychiatric disorders precluding understanding of the informed consent process and/or completion of the necessary studies.
• Active concurrent malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
• Symptomatic or untreated central nervous system (CNS) metastases.
• Pregnant or breast-feeding women.
• Known infection with HIV, hepatitis B or hepatitis C.
CONTACT
Please refer to this study by its ClinicalTrials.gov identifier: NCT00865969
Università Di Bologna
Bologna, Italy, 40138
Contact: Pier L Zinzani, MD
+39 051 6363680
plzinzo@med.unibo.it
Principal Investigator: Pier L. Zinzani, MD
ITALY: FIRENZE, MILAN, ROME, BOLOGNA and TORINO
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
ITALY: BOLOGNA, TURIN, FLORENCE, ROMA, MILAN
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
1-866-887-1291
mf@us.genmab.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
ITALY
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
POLAND
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
Klinika Dermatologii, Wenerologii i Alergologii
Gda?sk, Poland, 80-952
Contact: Malgorzata Sokolowska-Wojdylo, MD +48 (58) 349 25 80 mwojd@amg.gda.pl
Principal Investigator: Jadwiga ROSZKIEWICZ, Pr
Katedra i Klinika Dermatologii Akademii Medycznej w Bydgoszczy
Bydgoszcz, Poland, 85-096
Contact: Aleksandra Grzanka, MD +48 (52) 585-45-68 aleksandrag@op.pl
Principal Investigator: Waldemar PLACEK, Pr
SERBIA AND MONTENEGRO
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
Clinical Centre Serbia
Belgrade, Serbia and Montenegro, 11000
Contact: Biljana MIHALJEVIC, Pr +381 65 2457597 bimih@eunet.yu
Principal Investigator: Biljana MIHALJEVIC, Pr
SPAIN: MADRID
Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome
PURPOSE: The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides(MF) and sezary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.
ELIGIBILITY
Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No
Inclusion Criteria:
* A biopsy compatible with the diagnosis of MF and sezary syndrome with a CD4 positive phenotype within 6 months of study entry
* Refractory to or intolerant to at least two prior therapies, one being Targretin® (or combinations hereof).
* Signed informed consent
Exclusion Criteria:
* Prior treatment with combination chemotherapy within four weeks
* Prior treatment with Total Skin Electron Beam (TSEB) therapy within 6 months.
* Prior treatment with Campath (alemtuzumab)
* Prior treatment with more than three regimens of single agent chemotherapy
* Treatment within 4 weeks prior to study with topical Targretin®, skin directed therapies or systemic anticancer therapies.
* Serious intercurrent medical condition
* Acute or chronic infectious disease.
* Patient with a history of intermittent relapsing herpes simplex skin affections on prophylactic treatment with acyclovir and valacyclovir and patients taking dicloxillin for carriage of staphylococcus aureus maybe included.
* Breast feeding women or women with a positive pregnancy test
* Patients of childbearing potential must practice adequate contraception
CONTACT:
Zena Muzyczenko
215-279-3015
CTCL@tenxbiopharma.com
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127881
SPAIN: MADRID
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
SPAIN
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
SWITZERLAND
Study to Evaluate the Safety and Efficacy of Adeno-IFN Gamma in Cutaneous B-Cell Lymphoma
PURPOSE: The primary objective of this study is to evaluate the efficacy of a four-month dosing period of intra-lesional injection of TG1042 in patients with relapsing CBCL.
Patients will receive intra-tumoral injections of an adenoviral vector construct containing the human interferon gamma gene (TG1042), in an attempt to enhance immune responses with anti-tumor activity. This local administration induces tumour cell killing at the injected tumour sites.
INCLUSION:
Primary CBCL including (according to WHO/EORTC classification 2005) :
* Primary cutaneous marginal zone B-cell lymphoma
* Primary cutaneous follicle center B-cell lymphoma
* Primary cutaneous diffuse large B-cell other than leg type
* See full description for further inclusion details
EXCLUSION:
* Primary cutaneous diffuse large B-cell lymphoma, leg type.
* Primary cutaneous intravascular large B-cell lymphoma.
* Extracutaneous involvement (sign of B-cell lymphoma on thoraco-abdominal CT scan and/or PET scan and/or on bone marrow biopsy).
* No histologic documentation of CBCL.
* History of known Human Immuno-deficiency Virus, Human Hepatitis B or C positive serology or other active systemic infections.
* Serious uncontrolled, concomitant medical disorders.
* Concomitant therapy for CBCL: surgical resection, radiotherapy, corticosteroid, chemotherapy, rituximab…(not limited listing)
* Major surgery in previous 4 weeks preceding the 1st injection.
* Pregnancy at study entry or who become pregnant during the study or women who are breast feeding.
* Males and females of reproductive potential who refuse to use adequate protection against pregnancy (intra-uterine device, hormonal contraception or diaphragm/condom and spermicide) during the conduct of the study and for three months after the last injection.
* Participation in another experimental protocol during the study period and within 4 weeks prior to the first injection.
* Patient previously included in this study.
* Non compliance with the study.
Sponsor: Transgene
Identifier for www.clinicaltrials.gov: NCT00394693
CONTACT
University Hospital of Zurich
Zurich, Switzerland, 8090
Contact: Reinhard G. DUMMER, M.D. +41-44-255-2550 reinhard.dummer@usz.ch
Principal Investigator: Reinhard G. DUMMER, D.M.
SWITZERLAND: ZURICH
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
SWITZERLAND
A Phase II Study of Oral LBH589 in Adult Patients with Refractory Cutaneous T-Cell Lymphoma
PURPOSE: In light of the need for new treatment options for patients with previously treated CTCL, the purpose of this multinational, non randomized, phase II study is to assess the efficacy of oral LBH589 as single agent in patients with CTCL whose disease has progressed following or has not responded to at least two prior systemic treatment regimens.
Key Eligibility Criteria: Inclusion
1. Written informed consent obtained prior to any screening procedures
2. Age ≥ 18 years old
3. Patients with biopsy-confirmed mycosis fungoides or Sézary syndrome stages IB-IVA. Patients who have SS with bone marrow involvement are also eligible. Patients with transformed CTCL are eligible. Disease stage for eligibility is based on the stage at time of study enrollment. However, patients with any history of visceral involvement of their CTCL will not be eligible for this study.
4. Patients must have received at least two prior treatment regimens at least one of which was a systemic therapy regimens. Systemic regimens include oral bexarotene, PUVA, photophoresis, oral corticosteroids, total skin electron bean therapy, immunotherapy, chemotherapy such as methotrexate, biological response modifiers such as and interferon. Topical steroids alone are not considered as a treatment regimen.
5. Patients must have had disease progression on or following their most recent treatment regimen. Patients are also eligible if they had an inadequate response to their most recent treatment regimen defined as stable disease as the best response after at least 3 months of therapy.
6. Patients will be accrued to one of two groups:
• Group 1: Patients previously treated with oral bexarotene. This group includes patients who had:
1. Disease progression on following treatment oral bexarotene, OR
2. An inadequate response to oral bexarotene treatment defined as stable disease as the best response after at least 3 months of treatment, OR
3. Intolerance of oral bexoratene defined as patients who discontinued oral bexoratene treatment due to adverse events.
• Group 2: Patients who have not had prior oral bexarotene treatment.
Please contact the study site to see if you meet the other criteria for this study.
CONTACT INFORMATION
LeiA.Zhang@novartis.com
UNITED KINGDOM: MANCHESTER and LONDON
Single Agent Phase II Study of Forodesine (BCX1777) in the Treatment of Cutaneous T-Cell Lymphoma
PURPOSE: This study will enroll subjects with CTCL stages IB, IIA, IIB, III and IVA. The goal of this study is to determine if the investigational drug Forodesine Hydrochloride is a safe and effective treatment for cutaneous T-cell lymphoma or Sézary syndrome. Approximately 150 patients will participate in this study in up to 50 centers across North America, Europe, and Australia.
INCLUSION:
1. Males or non-pregnant femails aged ≥ 18 years
2. Histologically confirmed diagnosis of CTCL, including mycosis fungoides and/or Sézary syndrome
3. Subjects with CTCL stages IB, IIA, IIB, III and IVA
4. Must have failed 3 forms of systemic therapy, one of which must have been oral bexarotene, unless not tolerated or was medically contraindicated
EXCLUSION:
1. Proven or suspected extracutaneous visceral CTCL involvement (presence of lymphadenopathy is permitted)
2. Previous treatment with Forodesine
3. Concurrent treatment with any other anti-CTCL therapy
Protocal number: BioCryst Protocol BCX1777-203
Sponsor: BioCryst Pharmaceuticals Inc.
Identifier for www.clinicaltrials.gov: NCT00501735
CONTACT
Kathryn Hutchinson
44-208-9562-606
Kathryn.Hutchinson@ams-europe.com
Jennifer Edmondson
BioCryst Pharmaceuticals
919-859-7912
