A Study to Determine the Efficacy of Lenalidomide Versus Investigator's Choice in Patients With Relapsed or Refractory Mantle Cell Lymphoma (MCL) (Sprint)

Celgene

Status and phase: Completed; Phase 2

Conditions: Lymphoma, Mantle-Cell; Mantle Cell Lymphoma

Treatments: Drug: Lenalidomide; Drug: Investigators choice single agent

Study type: Interventional

Funder types: Industry

Identifiers

NCT00875667

CC-5013-MCL-002

Details and patient eligibility

About

To evaluate the safety and efficacy of lenalidomide versus investigator choice in patients with relapsed or refractory mantle cell lymphoma.

Full description

This research study is for patients who have relapsed or refractory mantle cell lymphoma following treatment such as radiotherapy, immunotherapy, chemotherapy, or radioimmunotherapy. Chemotherapy agents such as gemcitabine, cytarabine, chlorambucil, fludarabine, or the immunotherapeutic agent, rituximab, may be proposed. Thus, the aim is to search for new treatments that may improve the prognosis of patients with relapsed mantle cell lymphoma.

The present clinical study aims at determining if lenalidomide is safe and active in patients with mantle cell lymphoma who are refractory to their treatment or have relapsed once, twice or three times. Enrollment goal was met on March 7th 2013 and thus enrollment was stopped.

Enrollment: 254 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Biopsy proven mantle cell lymphoma
• Patients who are refractory to their regimen or have relapsed once, twice or up to three times and who have documented progressive disease
• Eastern Cooperative Oncology Group (ECOG) performance score 0,1, or 2
• Willing to follow pregnancy precaution

Exclusion criteria

• Any of the following laboratory abnormalities
• Absolute neutrophil count (ANC) < 1,500 cells/mm^3 (1.5 x 10^9/L)
• Platelet count < 60,000/mm^3 (60 x 10^9/L)
• Serum aspartate transaminase/serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/serum glutamic pyruvic transaminase (ALT/SGPT) >3.0 x upper limit or normal (ULN), except patients with documented liver involvement by lymphoma
• Serum total bilirubin > 1.5 x ULN, except in case of Gilbert's Syndrome and documented liver involvement by lymphoma.
• Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL/min
• History of active central nervous system (CNS) lymphoma within the previous 3 months
• Subjects not willing to take deep venous thrombosis (DVT) prophylaxis
• Known seropositive for or active viral infection with human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV). Patients who are sero-positive because of hepatitis B virus vaccine are eligible

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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254 participants in 2 patient groups

Lenalidomide

Experimental group

Description:

Lenalidomide

Treatment:

Drug: Lenalidomide

Investigators choice single agent

Active Comparator group

Description:

Investigators choice single agent - Chlorambucil, Rituximab, Cytarabine, Gemcitabine, Fludarabine

Treatment:

Drug: Investigators choice single agent