Overview

This trial is active, not recruiting.

Condition mantle cell lymphoma
Treatment lenalidomide
Phase phase 2
Sponsor Celgene Corporation
Start date December 2008
End date July 2012
Trial size 134 participants
Trial identifier NCT00737529, CC-5013-MCL-001

Summary

To evaluate the safety and efficacy of Lenalidomide (Revlimid (R)) in subjects with mantle cell lymphoma who have relapsed, progressed or are refractory to bortezomib.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Single agent Lenalidomide Lenalidomide: 10mg or 25 mg oral capsules on days 1 to 21 of each 28 day cycle and dependent on renal function; Participants with normal renal function (defined as Creatinine Clearance(CrCl)) of ≥ 60 mL/min in this study) received 25 mg of lenalidomide daily, and those with moderate renal insufficiency (CrCl) ≥ 30 mL/min but < 60 mL/min) were started at a 10-mg dose. Participants could continue to receive treatment until disease progression, development of unacceptable AEs, or voluntary withdrawal.
lenalidomide Revlimid
25mg oral capsules continuous days 1-21 each of a 28 day cycle

Primary Outcomes

Measure
Percentage of Participants With an Overall Response
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Duration of Response (DoR)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles and/or data cut-off of 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks

Secondary Outcomes

Measure
Time to Response (TTR)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Percentage of Participants With a Complete Response (CR) /Complete Response Unconfirmed (CRu)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; Data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Duration of Complete Response (DoCR) (CR+CRu)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Time to Complete Response (CR+CRu)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012: Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Time to Progression (TTP)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Time to Treatment Failure (TTF)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Progression-free Survival (PFS)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; and/or of the data-cut off of 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Overall Survival (OS)
time frame: Up to 6 cycles (+/- 1 month) or discontinued before completing 6 cycles; data cut-off 02 July 2012; Median duration on study was 44.3 weeks and ranged from 0.6 to 175.1 weeks
Summary of Participants With Treatment Emergent Adverse Events (TEAEs)
time frame: From the first dose of Lenalidomide through cycle 6 plus 28 days of last dose of Lenalidomide (maximum duration of study drug was 1006 days) and up to data cut off 02 July 2012

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Biopsy proven mantle cell lymphoma - Patients must have documents relapsed, refractory or PD after treatment with bortezomib - Must have measureable disease on cross sectional imaging by CT - Eastern Cooperative Oncology Group (ECOG) performance score 0,1 or 2 - Willing to follow pregnancy precautions Exclusion Criteria: - 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/Serum glutamic oxaloacetic transaminase(AST/SGOT) or alanine transaminase/Serum glutamic pyruvic transaminase (ALT/SGPT) > 3.0 x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma. - Serum total bilirubin > 1.5 x ULN, except in cases of Gilbert's Syndrome and documented liver involvement by lymphoma. - Calculated creatinine clearance (Cockcroft-Gault formula) of < 30 mL /min - Patients who are candidates for high dose chemotherapy/allogeneic stem cell transplant are not eligible - History of active central nervous system (CNS) lymphoma within the previous 3 months - Subjects not willing or unable to take deep vein thrombosis (DVT) prophylaxis - Prior history of malignancies, other than MCL, unless the patient has been free of the disease for ≥ 3 years - Positive Human immunodeficiency virus (HIV) or active Hepatitis B or C

Additional Information

Official title A Phase II, Multicenter, Single-Arm, Open-Label Study of Single-Agent Lenalidomide (Revlimid®) in Patients With Mantle Cell Lymphoma Who Have Relapsed After Bortezomib or Are Refractory or Intolerant to Bortezomib
Description Follow up phase will continue until either 100% of the patients have died, are lost to follow up or have withdrawn consent or a maximum of 4 years from the last patient enrolled, whichever comes first. All other efficacy and safety endpoints will be updated at this time. In the unlikely event that the study will be closed and patients are still responding to treatment at this time, Celgene will discuss with the treating physicians options to provide further treatment to the patient after study closure in line with local regulation. Follow up for second primary malignancies and OS will continue until 100% of the patients have died, are lost to follow up, have withdrawn consent, or a maximum of 5 years from the last patient enrolled, whichever comes first.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Celgene Corporation.