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Study of Lenalidomide in Combination With RICE With Lenalidomide Maintenance Post-Auto Transplant for DLBCL

NCT01241734 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-08

Study results available
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Summary

The standard of care therapy for DLBCL in the relapsed setting is RICE with the plan for the patient to proceed to transplant. This protocol will add Revlimid to the first 7 days of the RICE therapy and again after transplant as maintenance. To improve over all outcome and survival.

Hypothesis is that combining lenalidomide with standard of care (RICE) may increase overall response rate thus increasing the number of patients able to proceed with autologous stem cell transplant. This in turn may translate into improved overall survival and progression free survival.

Conditions

Interventions

DRUG

Revlimid

Stage I: Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7 Stage II: RICE + Lenalidomide at the MTD days 1-7 Stage III: Lenalidomide 25mg days 1-21 every 28 days

Sponsors & Collaborators

  • Celgene Corporation

    collaborator INDUSTRY

  • Hackensack Meridian Health

    lead OTHER

Principal Investigators

  • Tatyana Feldman, MD · Hackensack Meridian Health

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2014-12-31
Completion
2015-09-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01241734 on ClinicalTrials.gov