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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
N/A
Open (Enrolling)
Both
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
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

Type of Study:

Interventional

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:

No

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

Authority:

United States: Food and Drug Administration

Study ID:

RV-FOL-GELARC-0683C

NCT ID:

NCT01476787

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

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
MD Anderson Cancer CenterHouston, Texas  77030-4096
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
University of Nebraska Medical CenterOmaha, Nebraska  68198-3330
Florida Cancer SpecialistsFort Myers, Florida  33901
Memorial HospitalColorado Springs, Colorado  80909
Seattle Cancer Care AllianceSeattle, Washington  98109
Holy Cross HospitalFort Lauderdale, Florida  33308
Sarah Cannon Cancer CenterNashville, Tennessee  37203
University of KentuckyLexington, Kentucky  40536-0098
Virginia Cancer InstituteRichmond, Virginia  23230
Compassionate Cancer Care medical Group, Inc.Fountain Valley, California  92708
Somerset Hematology Oncology AssociatesSomerset, New Jersey  08873
Kentucky Cancer ClinicPikeville, Kentucky  41501
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
St. Luke's-Roosevelt Hospital CenterNew York, New York  
Florida Cancer SpecialistFort Myers, Florida  33901
Santa Monica Hematology/OncologySanta Monica, California  90404
The Cancer Center at Hackensack University Medical CenterHackensack, New Jersey  07601
Roger Maris Cancer CenterFargo, North Dakota  58122
St. Jude Heritage Medical GroupFullerton, California  92835
Cancer Center of Central ConnecticutSouthington, Connecticut  
Baylor Sammons Cancer CenterDallas, Texas  75246
Advocate Illinois Masonic Medical CenterChicago, Illinois  60657
Newland Medical AssociatesSouthfield, Michigan  48075
University Cancer InstituteBoyton Beach, Florida  33426
Lalita Pandit, MD Inc.Fountain Valley, California  92708
Saint Joseph's Medical CenterWestminister, Maryland  21157
Harvard Medical School-Mass General HospitalBoston, Massachusetts  02114
Washington University School of Medicine Siteman Cancer Center Hematology LabsSt. Louis, Missouri  63141
Hematology-Oncology Associates of North New JerseyMorristown, New Jersey  07960
Ochsner Clinic Baton RougeBaton Rouge, Louisiana  70809