Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322985
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2006-05-05
Brief Title:
A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkins Lymphoma
Sponsor:
AHS Cancer Control Alberta
Organization:
AHS Cancer Control Alberta
Study Overview
Official Title:
A Phase II Clinical Trial of Lenalidomide for T-cell Non-Hodgkins Lymphoma
Status:
COMPLETED
Status Verified Date:
2016-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
T-cell Non-Hodgkins lymphomas are a group of cancers that are usually treated with chemotherapy radiation therapy or occasionally surgery T-cell lymphomas are relatively uncommon and therefore not well studied Treatment approaches are patterned after the more common B-cell lymphomas T-cell lymphomas are more likely to relapse following standard therapy than are B-cell lymphomas New therapies are needed for T-cell lymphomas In this study we will administer the drug called lenalidomide as a pill to patients with T-cell lymphoma The goals are to determine if the drug can induce regression of the cancer and to determine if the treatment is well tolerated in this patient group This study will take place at six cancer centres across Canada
Detailed Description:
Background T-cell lymphomas comprise 10-15 of all non-Hodgkins lymphomas and include a variety of histological subtypes These diseases have variable clinical behaviour response to therapy and long-term outcomes In general T-cell lymphomas are characterized by inferior response to therapy and prognosis compared to the more common B-cell lymphomas Because T-cell lymphomas are uncommon they are not generally well studied and current treatment approaches are borrowed from established protocols for B-cell lymphoma New therapies are needed for T-cell lymphoma and should be studied separately for their effectiveness in T-cell lymphoma
Lenalidomide CC-5013 Revlimid Celgene Corporation is an oral thalidomide analogue with anti-cancer activity Lenalidomide is generally well tolerated with rash myelosuppression and venous thrombosis being the most notable and common potential side effects Lenalidomide has demonstrated impressive anti-cancer activity against mycosis fungoides cutaneous T-cell lymphoma multiple myeloma chronic lymphocytic leukemia and myelodysplasia The drug is currently under review by Health Canada as a potential new standard therapy for multiple myeloma We are encouraged by the efficacy and tolerability of lenalidomide in patients with related diseases to study its role in the treatment of T-cell lymphomas other than mycosis fungoides
Primary Objective To determine the overall response rate to single agent lenalidomide at standard doses 25 mg po daily for 21 days of a 28-day cycle as a treatment for T-cell lymphoma
Secondary Objectives To determine the complete response rate time to progression overall survival and tolerability for patients with T-cell lymphoma treated with lenalidomide
Study Design A multi-centre Canadian Phase II investigator-initiated clinical trial
Inclusion Criteria
Patients with the following subtypes of T-cell lymphoma
Peripheral T-cell lymphoma unspecified
Angioimmunoblastic T-cell lymphoma
Enteropathy-type T-cell lymphoma
NKT-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitic-like T-cell lymphoma
Anaplastic large cell lymphoma
Lymphoblastic T-cell lymphoma Measurable disease See section 62 WHO performance status of 0-2 Both untreated patients with contraindications to chemotherapy and patients with relapsedrefractory disease after at least one line of chemotherapy are allowed no restriction on the number of prior therapies Patients with prior radiotherapy autologous or allogeneic stem cell transplant are allowed Age 18 years able to give informed consent Acceptable hematological and biochemical parameters see section 62
Exclusion Criteria
Mycosis FungoidesSezary Syndrome Pregnant or lactating females Concurrent use of other anti-cancer therapies Other serious co-morbid illness that would compromise participation in the study Prior therapy with lenalidomide Prior hypersensitivity to thalidomide
It is intended to enroll patients who have relapsed in spite of chemotherapy radiotherapy andor high dose therapy with stem cell transplant or patients who are not eligible for these standard therapies It would be encouraged that patients are initially treated with standard therapy if possible However we wish to allow untreated patients to participate because older frail patients with disseminated T-cell lymphoma or patients with significant comorbidities may not be eligible for aggressive chemotherapy but may tolerate lenalidomide quite well In this regard it is left to the discretion of the investigator to determine whether or not an individual patient should be considered for enrollment on this clinical trial or whether that patient would be better served with standard treatment approaches
Recruitment will take place in the outpatient clinics of the Cross Cancer Institute and five other Canadian cancer clinics Vancouver Calgary Winnipeg Ottawa Halifax The Cross Cancer Institute will be the lead site for the trial and our team will be responsible for oversight of the trial collation of patient case report forms communication with Health Canada and Celgene and data analysis Celgene will monitor all the sites involved in the trial every 3-4 months
Statistical Analysis will use standard methods and will include a data safety and monitoring committee DSMB who will perform interim safety analyses after ten and 22 patients have been enrolled on trial An interim efficacy analysis will be performed after 22 patients have been enrolled The trial will be stopped if fewer than 2 of the first 22 patients enrolled achieve an objective response to therapy according to standard criteria If two or more responses occur the trial will continue until the remaining 18 patients will be accrued in the absence of safety concerns There are no pre-specified criteria for stopping the trial on the basis of safety concerns but the investigators and the independent DSMB will each have the power to halt enrollment if serious safety concerns arise at any point during the trial Patients will be required to stop the study treatment if severe adverse reactions occur the lymphoma progresses serious intercurrent illness interferes with treatment suspected pregnancy occurs or for major study protocol violations
Sample size For a total of 40 subjects 22 will be accrued during stage 1 and 18 during stage 2 If 1 or fewer responses are observed during the first stage then the trial is stopped early Given that the true response probability is 5 there is a 70 probability of ending the trial during stage 1 However if the true response probability is 20 then there is a 5 probability that the trial will be stopped in stage 1 The alpha level of the design is 004 and the power is 09 If fewer than 4 of 40 patients respond this will be considered evidence that lenalidomide is inactive in the population studied
Lenalidomide CC-5013 Revlimid Celgene Corporation is an oral thalidomide analogue with anti-cancer activity Lenalidomide is generally well tolerated with rash myelosuppression and venous thrombosis being the most notable and common potential side effects Lenalidomide has demonstrated impressive anti-cancer activity against mycosis fungoides cutaneous T-cell lymphoma multiple myeloma chronic lymphocytic leukemia and myelodysplasia The drug is currently under review by Health Canada as a potential new standard therapy for multiple myeloma We are encouraged by the efficacy and tolerability of lenalidomide in patients with related diseases to study its role in the treatment of T-cell lymphomas other than mycosis fungoides
Primary Objective To determine the overall response rate to single agent lenalidomide at standard doses 25 mg po daily for 21 days of a 28-day cycle as a treatment for T-cell lymphoma
Secondary Objectives To determine the complete response rate time to progression overall survival and tolerability for patients with T-cell lymphoma treated with lenalidomide
Study Design A multi-centre Canadian Phase II investigator-initiated clinical trial
Inclusion Criteria
Patients with the following subtypes of T-cell lymphoma
Peripheral T-cell lymphoma unspecified
Angioimmunoblastic T-cell lymphoma
Enteropathy-type T-cell lymphoma
NKT-cell lymphoma
Hepatosplenic T-cell lymphoma
Subcutaneous panniculitic-like T-cell lymphoma
Anaplastic large cell lymphoma
Lymphoblastic T-cell lymphoma Measurable disease See section 62 WHO performance status of 0-2 Both untreated patients with contraindications to chemotherapy and patients with relapsedrefractory disease after at least one line of chemotherapy are allowed no restriction on the number of prior therapies Patients with prior radiotherapy autologous or allogeneic stem cell transplant are allowed Age 18 years able to give informed consent Acceptable hematological and biochemical parameters see section 62
Exclusion Criteria
Mycosis FungoidesSezary Syndrome Pregnant or lactating females Concurrent use of other anti-cancer therapies Other serious co-morbid illness that would compromise participation in the study Prior therapy with lenalidomide Prior hypersensitivity to thalidomide
It is intended to enroll patients who have relapsed in spite of chemotherapy radiotherapy andor high dose therapy with stem cell transplant or patients who are not eligible for these standard therapies It would be encouraged that patients are initially treated with standard therapy if possible However we wish to allow untreated patients to participate because older frail patients with disseminated T-cell lymphoma or patients with significant comorbidities may not be eligible for aggressive chemotherapy but may tolerate lenalidomide quite well In this regard it is left to the discretion of the investigator to determine whether or not an individual patient should be considered for enrollment on this clinical trial or whether that patient would be better served with standard treatment approaches
Recruitment will take place in the outpatient clinics of the Cross Cancer Institute and five other Canadian cancer clinics Vancouver Calgary Winnipeg Ottawa Halifax The Cross Cancer Institute will be the lead site for the trial and our team will be responsible for oversight of the trial collation of patient case report forms communication with Health Canada and Celgene and data analysis Celgene will monitor all the sites involved in the trial every 3-4 months
Statistical Analysis will use standard methods and will include a data safety and monitoring committee DSMB who will perform interim safety analyses after ten and 22 patients have been enrolled on trial An interim efficacy analysis will be performed after 22 patients have been enrolled The trial will be stopped if fewer than 2 of the first 22 patients enrolled achieve an objective response to therapy according to standard criteria If two or more responses occur the trial will continue until the remaining 18 patients will be accrued in the absence of safety concerns There are no pre-specified criteria for stopping the trial on the basis of safety concerns but the investigators and the independent DSMB will each have the power to halt enrollment if serious safety concerns arise at any point during the trial Patients will be required to stop the study treatment if severe adverse reactions occur the lymphoma progresses serious intercurrent illness interferes with treatment suspected pregnancy occurs or for major study protocol violations
Sample size For a total of 40 subjects 22 will be accrued during stage 1 and 18 during stage 2 If 1 or fewer responses are observed during the first stage then the trial is stopped early Given that the true response probability is 5 there is a 70 probability of ending the trial during stage 1 However if the true response probability is 20 then there is a 5 probability that the trial will be stopped in stage 1 The alpha level of the design is 004 and the power is 09 If fewer than 4 of 40 patients respond this will be considered evidence that lenalidomide is inactive in the population studied
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None