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). (RENEW)

Celgene

Status and phase: Terminated; Phase 3

Conditions: Non-Hodgkin's Lymphoma; Mantle Cell Lymphoma

Treatments: Drug: Lenalidomide; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01021423

CC-5013-MCL-003

Details and patient eligibility

About

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This study was prematurely terminated by the sponsor in light of new unpublished data that rendered the current design of the study no longer clinically relevant.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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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
• Subjects at high risk for deep vein thrombosis (DVT) not willing to take DVT prophylaxis
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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9 participants in 2 patient groups

Lenalidomide

Experimental group

Description:

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.

Treatment:

Drug: Lenalidomide

Placebo

Experimental group

Description:

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.

Treatment:

Other: Placebo