A PHASE 2, MULTICENTER, SINGLE-ARM, OPEN-LABEL STUDY TO DETERMINE THE EFFICACY AND SAFETY OF SINGLE-AGENT LENALIDOMIDE (REVLIMID) IN PATIENTSWITH MANTLE CELL NHL WHO HAVE RELAPSED OR PROGRESSED AFTER TREATMENT WITH BORTEZOMIB OR ARE REFRACTORY TO BORTEZOMIB - ND
- Conditions
- PATIENTS WITH MANTLE CELL NHL WHO HAVE RELAPSED OR PROGRESSED AFTER TREATMENT WITH BORTEZOMIB OR ARE REFRACTORY TO BORTEZOMIBMedDRA version: 9.1Level: HLTClassification code 10026798Term: Mantle cell lymphomas
- Registration Number
- EUCTR2007-007756-34-IT
- Lead Sponsor
- Celgene Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 133
Biopsy-proven mantle cell NHL, including overexpression of cyclin D1 by immunohistochemistry or t(11;14)(q13;q32) by FISH. In patients whose tumors are negative for the cyclin D1 overexpression or translocation, evidence of overexpression of cyclin D2 or D3 by immunohistochemistry will be acceptable. Must have received all of the following agents (alone or in combination). (There is no limit on the number of agents or prior therapies). The following agents can be given in any combination:  Anthracycline or mitoxantrone  Cyclophosphamide  Rituximab  Bortezomib Patients must have documented relapsed, refractory or PD after treatment with bortezomib (or a bortezomib containing regimen) based on the following definitions:  Relapsed lymphoma: patients with relapse within one year of last dose of bortezomib (or a bortezomib containing regimen) following initial response of CR to bortezomib (or a bortezomib containing regimen)  Lymphoma refractory to bortezomib: patients with PD without any documented response of PR or better during treatment with bortezomib (or a bortezomib containing regimen) and having received at least 2 cycles of bortezomib (or a bortezomib containing regimen)  Progressive disease: patients with PD within one year of last dose of bortezomib (or bortezomib containing regimen) following initial response of PR to bortezomib (or a bortezomib containing regimen) Patients who have relapsed following high dose chemotherapy/autologous stem cell transplant are eligible. Must have measurable disease on cross sectional imaging by CT that is at least 2 cm in the longest diameter and measurable in two perpendicular dimensions. Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2. Life expectancy of ≥ 90 days (3 months). Females of child-bearing potential (FCBP) must agree to:  Have two medically supervised pregnancy tests prior to starting of study therapy. The first pregnancy test will be performed within 10-14 days prior to the start of lenalidomide and the second pregnancy test will be performed within 24 hours prior to the start of lenalidomide. She must also agree to ongoing pregnancy testing during the course of the study, and after the end of study therapy (See specifics as described in Appendix 21.5 and 21.6). This applies even if the patient practices complete and continued sexual abstinence.  Either commit to continued abstinence from heterosexual intercourse (which must be reviewed on a monthly basis) or agree to use, and be able to comply with, effective contraception without interruption, 28 days prior to starting study drug, during the study therapy (including dose interruptions), and for 28 days after discontinuation of study therapy (See specifics as described in Appendix 21.5 and 21.6).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Diagnosis of lymphoma other than MCL. Transformed lymphoma Any of the following laboratory abnormalities. Absolute neutrophil count (ANC) < 1,500 cells/mm3 (1.5 x 109/L). Platelet count < 60,000/mm3 (60 x 109/L). Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) 5.0 x upper limit of normal (ULN). Serum total bilirubin > 2.0 mg/dL (34 µmol/L)/conjugated bilirubin > 0.8mg/dL, except in case of hemolytic anemia. Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min Active central nervous system (CNS) lymphoma with the exception of those patients whose CNS lymphoma has been treated with chemotherapy, radiotherapy or surgery, have remained asymptomatic for 90 days (3 months) and demonstrate no CNS lymphoma as shown by lumbar puncture, CT are eligible. Patients with a history of CNS involvement or CNS symptoms will be required to have negative cerebrospinal fluid (CSF) cytology examination and a head CT during the screening period Patients who have relapsed following allogeneic stem cell transplant and who have persistent donor hematopoiesis are not eligible. Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible. Patients should not be receiving corticosteroids except for prednisone ≤ 10 mg/day or equivalent for purposes other than treating MCL.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the tumor response and duration of response of lenalidomide monotherapy in patients with mantle cell lymphoma (MCL) who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib;Secondary Objective: To evaluate the safety of lenalidomide monotherapy in patients with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib To determine the time to progression (TTP), time to complete response (CR)/ complete response unconfirmed (CRu), time to treatment failure (TTF), progression-free survival (PFS) and overall survival (OS) of lenalidomide monotherapy in patients with MCL who have relapsed or progressed after treatment with bortezomib or are refractory to bortezomib;Primary end point(s): Tumor Response (assessed by a modification of the International Lymphoma Workshop Response Criteria (IWRC) (Cheson, 1999) and Duration of Response
- Secondary Outcome Measures
Name Time Method