A Phase 3 Multicenter, Randomized, Double-blind, Placebo-Controlled, First Line Maintenance Study Of Lenalidomide (Revlimid®) In Patients With Mantle-Cell Lymphoma
Overview
- Phase
- Phase 3
- Intervention
- Lenalidomide
- Conditions
- Mantle Cell Lymphoma
- Sponsor
- Celgene
- Enrollment
- 9
- Locations
- 91
- Primary Endpoint
- Progression-free Survival (PFS)
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
A study to evaluate the efficacy of lenalidomide as maintenance therapy after completion of first-line combination chemotherapy in patients with mantle cell lymphoma (MCL) who are not candidates for transplantation and have achieved partial response (PR) or complete response (CR).
This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant. A study design with the control arm of no active treatment was no longer appropriate. The termination of the trial was not based on any safety concerns in the study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Histologically-proven mantle cell non-Hodgkin's lymphoma,
- •One of the following first-line induction chemotherapy regimens with rituximab: (1) combination regimen containing all of the following components: cyclophosphamide, vincristine, adriamycin and a glucocorticoid; (2) Fludarabine containing regimen such as FC (fludarabine, cyclophosphamide)
- •Achieved a PR or better response after the first-line induction chemotherapy regimen (assessed by 2007 Revised Response Criteria for Malignant Lymphoma)
- •ECOG performance status score of ≤ 2
- •Willing to follow pregnancy precaution
Exclusion Criteria
- •Patients who have received more than 1 line of induction chemotherapy;
- •Patients who have received less than 4 cycles of R-CHOP, R-CHOP-like, or R-FC are ineligible;
- •Patients who achieved stable disease or progressive disease as best response with first line-induction chemotherapy;
- •Any of the following laboratory abnormalities:
- •Absolute neutrophil count (ANC) \< 1,500 cells/mm3 (1.5\*10\^9/L)
- •Platelet count \< 60,000/mm\^3 (60\*10\^9/L)
- •Serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT)) \> 3.0 times upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
- •Serum bilirubin \> 1.5 times ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma
- •Calculated creatinine clearance (i.e. Cockcroft-Gault formula) of \< 30 mL /min
- •Active or any history of central nervous system (CNS) lymphoma or leptomeningeal involvement by lymphoma
Arms & Interventions
Lenalidomide
Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Intervention: Lenalidomide
Placebo
Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
Intervention: Placebo
Outcomes
Primary Outcomes
Progression-free Survival (PFS)
Time Frame: up to 7 years
PFS is defined as the time from randomization into the study to the first observation of disease progression or death due to any cause. Progression, as defined by the 2007 Revised Response Criteria for Malignant Lymphoma (Cheson, 2007), is any new lesion or increase by 50% of previously involved sites from nadir. Study terminated prematurely. Analysis not conducted.
Secondary Outcomes
- Overall Survival(up to 7 years)
- Participants With Treatment Emergent Adverse Events (TEAEs)(up to 9 months)
- Time to Progression(up to 7 years)
- Time to Treatment Failure(up to 2 years)
- Participants With a Tumor Response(up to 7 years)