Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA
Dates
study started
estimated completion

Description

Summary

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.

Official Title

A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy in Subjects With Previously Untreated Follicular Lymphoma

Details

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.

Keywords

Follicular Lymphoma Non-Hodgkins Follicular Lymphoma treatment for Follicular Lymphoma rituximab treatment rituximab and lenalidomide treatment Lymphoma Lymphoma, Follicular Rituximab Lenalidomide Bendamustine Hydrochloride Rituximab-CHOP Rituximab-CVP Rituximab-Bendamustine Lenalidomide + Rituximab

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • Santa Monica Hematology Oncology
    Los Angeles California 90095 United States
  • Lalita Pandit, MD Inc.
    Fountain Valley California 92708 United States
  • Providence St Joseph Medical Center Cancer Center
    Burbank California 91505 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Celgene
ID
NCT01476787
Phase
Phase 3
Study Type
Interventional
Last Updated