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A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma. The "RELEVANCE" Trial (Rituximab Lenalidomide Versus Any Chemotherapy)

Phase 3
18 Years
Open (Enrolling)
Follicular Lymphoma

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Trial Information

A Phase 3 Open-Label Randomized Study to Compare the Efficacy and Safety of Rituximab Plus Lenalidomide (CC-5013) Versus Rituximab Plus Chemotherapy Followed by Rituximab in Subjects With Previously Untreated Follicular Lymphoma. The "RELEVANCE" Trial (Rituximab Lenalidomide Versus Any Chemotherapy)

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.

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

- 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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Complete response (CR/CRu) rate for Follicular Lymphoma

Outcome Description:

Response evaluation was as defined by International Working Group (IWG) Response Criteria (Cheson 1999). Complete response (CR) is defined as the complete disappearance of all detectable clinical and radiographic evidence of disease and the disappearance of all disease-related symptoms if present before therapy. Complete response unconfirmed (CRu) is defined as those patients who fulfill the criteria for CR above but with with indeterminant bone marrow or with residual disease that has decreased in size by greater than 75%.

Outcome Time Frame:

120 weeks

Safety Issue:


Principal Investigator

Nathan H Fowler, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Assistant Professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX


United States: Food and Drug Administration

Study ID:




Start Date:

November 2011

Completion Date:

June 2024

Related Keywords:

  • Follicular Lymphoma
  • Follicular lymphoma
  • Non-Hodgkins Follicular Lymphoma
  • treatment for Follicular Lymphoma
  • rituximab treatment
  • rituximab and lenalidomide treatment
  • Lymphoma
  • Lymphoma, Follicular



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