Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma (RELEVANCE)

Celgene logo

Celgene

Status and phase

Active, not recruiting
Phase 3

Conditions

Follicular Lymphoma

Treatments

Drug: Rituximab-CVP
Drug: Rituximab
Drug: Rituximab-Bendamustine
Drug: Rituximab-CHOP
Drug: Lenalidomide

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01476787
RV-FOL-GELARC-0683C
2011-002792-42 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to evaluate the effect of the combined treatment of lenalidomide and rituximab in controlling the Follicular Lymphoma disease and also increase the length of response compared to the available standard combination chemotherapy treatment for Follicular Lymphoma.

Full description

Follicular Lymphoma (FL) is a cancer of a B lymphocyte, a type of white blood cell. FL is typically a slowly progressing but incurable disease. Follicular lymphoma cells produce a specific defect in the patient's immune system impairing their ability to control their cancer. Lenalidomide has been shown to reverse the specific immune defect caused by FL in the patient. By including lenalidomide, the RELEVANCE study aims to eliminate the cancer while restoring the patient's immune competence. The 'Relevance' cooperative group trial is being conducted as two companion studies: RV-FOL-GELARC-0683 (N=750) and RV-FOL-GELARC-0683C (N=250); the combined total of 1000 Follicular Lymphoma patients enrolled in both studies will be analyzed.

Enrollment

255 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Histologically confirmed follicular lymphoma grade 1, 2 or 3a, Stage II-IV
  • Have no prior systemic treatment for lymphoma
  • Symptomatic follicular lymphoma requiring treatment.
  • Age ≥18 years
  • Eastern Cooperative oncology group performance status 0-2
  • Willing to follow pregnancy precautions

Exclusion criteria

  • Clinical evidence of transformed lymphoma or Grade 3b follicular lymphoma.
  • Major surgery (excluding lymph node biopsy) within 28 days prior to signing informed consent.
  • Known seropositive for or active viral infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV)
  • Known sensitivity or allergy to murine products.
  • Presence or history of central nervous system involvement by lymphoma
  • At high risk for a venous thromboembolic event (VTE) and not willing to take VTE prophylaxis

Any of the following laboratory abnormalities:

  • serum aspartate transaminase or alanine transaminase > 3x upper limit of normal (ULN), except in patients with documented liver involvement by lymphoma
  • total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and documented liver or pancreatic involvement by lymphoma
  • creatinine clearance of < 30 mL/min

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

255 participants in 2 patient groups

Lenalidomide + Rituximab
Experimental group
Description:
Lenalidomide dose 20-mg on days 2-22 every 28 days for 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for up to 18 cycles. Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Treatment:
Drug: Lenalidomide
Drug: Rituximab
Control
Active Comparator group
Description:
• ONE of the following: Rituximab-CHOP, Rituximab-CVP, Rituximab-Bendamustine. 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
Treatment:
Drug: Rituximab-Bendamustine
Drug: Rituximab-CHOP
Drug: Rituximab-CVP

Trial contacts and locations

10

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems