Study of Lenalidomide to Evaluate Safety and Effectiveness in Patients With Diffuse Large B Cell Lymphoma

This study is currently recruiting participants.
Verified June 2012 by Celgene Corporation

First Received on July 29, 2010.  
Last Updated on June 27, 2012  
History of Changes
This Clinical Trial Sponsored By: Celgene Corporation
Information provided by (Responsible Party): Celgene Corporation
ClinicalTrials.gov Identifier: NCT01197560
 

Purpose for Clinical Trial

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.

Condition Study Intervention Clinical Trial Phase
Diffuse Large B-cell Lymphoma Drug: Lenalidomide
Drug: Gemcitabine
Drug: Oxaliplatin
Drug: Rituximab
Drug: Etoposide
Phase 2
Phase 3

Study Type: Study Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Study Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics:
Lymphoma
Drug Information available for:
Etoposide
Oxaliplatin
Gemcitabine
Etoposide phosphate
Gemcitabine hydrochloride
Rituximab
Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures For Clinical Trial:

  • Stage 1: Overall response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3 years ] [ Designated as safety issue: No ]
    Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Stage 2: Progression-free survival for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Number of participants who survive without progressing based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

Secondary Outcome Measures For Clinical Trial:

  • Stage 2: Complete response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Complete Response + Complete Response unconfirmed based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Stage 2: Overall response rate for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Complete Response + Complete Response unconfirmed + Partial Response based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Stage 2: Duration of overall response for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Length of time of overall response (Complete Response + Complete Response unconfirmed + Partial Response) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Stage 2: Overall survival (OS) for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Number of participants who survive

  • Stage 2: Duration of complete response for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Length of time of complete response (Complete Response + Complete Response unconfirmed) based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Overall response rate for for Diffuse Large B-Cell Lymphoma (DLBCL) patients with a duration of response lasting ≥ 16 weeks [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Complete Response + Complete Response unconfirmed + Partial Response for participants with a duration of response lasting ≥ 16 weeks based on the International Lymphoma Workshop Response Criteria [IWRC] (Cheson 1999).

  • Time to progression for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Length of time until disease progression occurs

  • Number of Diffuse Large B-Cell Lymphoma (DLBCL) patients with adverse events [ Time Frame: Approximately 3.5 years. ] [ Designated as safety issue: Yes ]
  • Health Related Quality of Life for Diffuse Large B-Cell Lymphoma (DLBCL) patients [ Time Frame: Approximately 3.5 years ] [ Designated as safety issue: No ]
    Quality of Life based on the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 and the EQ-5D assessments

Estimated Enrollment: 400
Study Start Date: September 2010
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)

Arms

Assigned Study Interventions

Experimental: Lenalidomide Drug: 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: Investigator’s Choice

One of the following:

Lenalidomide, Gemcitabine, Oxaliplatin, Rituximab, or Etoposide

Drug: 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

Drug: Oxaliplatin

Suggested starting dose and regimen for Oxaliplatin is 100 mg/m2 IV day 1 for 21 days for 6 Cycles

Drug: 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)

Drug: Etoposide

Suggested starting doses for Etoposide are

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