Overview

This trial is active, not recruiting.

Condition diffuse large b-cell lymphoma
Treatments lenalidomide, gemcitabine, oxaliplatin, rituximab, etoposide
Phase phase 2/phase 3
Target CD20
Sponsor Celgene Corporation
Start date September 2010
End date July 2013
Trial size 111 participants
Trial identifier NCT01197560, CC-5013-DLC-001

Summary

The purpose of this study is to compare lenalidomide to a control drug and see which one delays Diffuse Large B-Cell Lymphoma (DLBCL) disease progression longer.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
lenalidomide
Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
(Active Comparator)
One of the following: Lenalidomide, Gemcitabine, Oxaliplatin, Rituximab, or Etoposide
gemcitabine
Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m2 IV days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m2 IV days 1 and 15 every 28 days for 6 Cycles
oxaliplatin
Suggested starting dose and regimen for Oxaliplatin is 100 mg/m2 IV day 1 for 21 days for 6 Cycles
rituximab
Suggested starting dose for Rituximab is 375 mg/m2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
etoposide
Suggested starting doses for Etoposide are: 100 mg/m2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m2 oral days 1-10 every 28 days for 6 Cycles

Primary Outcomes

Measure
Stage 1: Percentage of Participants With an Overall Response Rate (ORR) According to the International Working Group (IWG) Response Criteria for Non Hodgkin's Lymphoma (NHL), Cheson 1999.
time frame: From Sept 2010 to the data cut-off of 4 July 2013; when all participants had reached the scheduled 16-week assessment or had progressed/died before the scheduled 16-week assessment). Median follow-up time was 6.7 and 4.7 months in each arm respectively
Stage 2: Progression-free Survival for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:

Secondary Outcomes

Measure
Stage 2: Complete Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:
Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:
Stage 2: Duration of Overall Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame: Approximately 3.5 years
Stage 2: Overall Survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:
Stage 2: Duration of Complete Response for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:
Stage 2: Overall Response Rate for Diffuse Large B-Cell Lymphoma (DLBCL) Patients With a Duration of Response Lasting ≥ 16 Weeks
time frame:
Stage 2: Time to Progression for Diffuse Large B-Cell Lymphoma (DLBCL) Participants
time frame:
Stage 2: Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) Patients
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Histologically proven Diffuse Large B-Cell Lymphoma (DLBCL). - Relapsed or refractory to combination chemotherapy for DLBCL that contains rituximab and an anthracycline, and one additional combination chemotherapy or stem cell transplant. - Measurable DLBCL disease by computed tomograph (CT) / magnetic resonance imagining (MRI). - Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. Exclusion Criteria: - Diagnosis of lymphoma histologies other than DLBCL. - History of malignancies, other than DLBCL, unless the patient has been disease free for 3 years or more. - Eligible for autologous stem cell transplant. - Known seropositive for, or history of, active human immunodeficiency virus (HIV) hepatitis B virus (HBV), hepatitis C virus (HCV) - Neuropathy grade 4.

Additional Information

Official title A Phase 2/3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of Lenalidomide (Revlimid ®) Versus Investigator's Choice in Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma
Description This research study is for patients who have been diagnosed with Diffuse Large B-cell Lymphoma (DLBCL) that did not respond to (refractory) or that has come back after chemotherapy treatment (relapsed). Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. Within DLBCL there are two different subtypes called Germinal Center B-cell (GCB) and non-GCB which can be determined by cell surface marker tests or by gene expression tests. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don't know yet what the difference means. To patients and doctors these two kinds seem the same. Right now doctors don't usually do tests to find out which kind a patient has because the treatment is the same for both. This study will have two stages, 1 and 2. The main purpose of Stage 1 is to separate patients by subtype and then test whether patients taking lenalidomide or any one of four other drugs have a better response. It is possible that lenalidomide will work better than one of the other drugs in zero, one, or both subtypes. Stage 2 will further test only the subtype(s) from Stage 1 that showed a good response to lenalidomide. The main purpose of Stage 2 is to test how long patients are disease free on lenalidomide compared to one of the four other drugs. On 29 January 2013 the enrolment goal for the Stage 1 portion of the study was met and enrollment was stopped. The final analysis for Stage 1 was performed as of the 04 Jul 2013 data cutoff date. According to the Stage 1 results as assessed by the independent response adjudication committee (IRAC), neither subtype met the pre specified requirement to be further studied in Stage 2. Additionally, a suitable assay for the selection of participants for the Stage 2 study was not available. Therefore, on 6 January 2014, Celgene decided to not open Stage 2.
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Celgene Corporation.