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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)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 Patients Enrolled in Both Studies Will be Analyzed.


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)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 Patients Enrolled in Both Studies Will be Analyzed.


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.


Inclusion Criteria:



- Histologically confirmed CD20+ follicular lymphoma grade 1, 2 or 3a

- Have no prior systemic treatment for lymphoma.

- Must be in need of treatment

- Bi-dimensionally measurable disease with at least one mass lesion > 2 cm that was not
previously irradiated.

- Stage II, III or IV disease.

- Must be ≥ 18 years and sign an informed consent.

- Performance status ≤ 2 on the ECOG scale.

- Adequate hematological function (unless abnormalities are related to lymphoma
infiltration of the bone marrow)

- Willing to follow pregnancy precautions

Exclusion Criteria:

- Clinical evidence of transformed lymphoma by investigator assessment or Grade 3b
follicular lymphoma.

- Patients taking corticosteroids during the last 4 weeks, unless administered at a
dose equivalent to < 10 mg/day prednisone (over these 4 weeks).

- 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)or human immunodeficiency virus (HIV).

- Life expectancy < 6 months.

- Known sensitivity or allergy to murine products.

- Prior history of malignancies, other than follicular lymphoma, unless the patient has
been free of the disease for ≥ 10 years.

- Prior use of lenalidomide.

- Neuropathy > Grade 1.

- Presence or history of CNS involvement by lymphoma.

- Patients who are at a high risk for a thromboembolic event and are not willing to
take venous thromboembolic (VTE) prophylaxis.

- serum aspartate transaminase (AST/SGOT) or alanine transaminase (ALT/SGPT) > 3x upper
limit of normal (ULN), except in patients with documented liver or pancreatic
involvement by lymphoma

- total bilirubin > 2.0 mg/dl (34 µmol/L) except in cases of Gilberts Syndrome and
documented liver involvement by lymphoma

- creatinine clearance of < 30 mL/min

- Pregnant or lactating females.

- Any condition, including the presence of laboratory abnormalities, which places the
patient at unacceptable risk if he/she were to participate in the study, or which
confounds the ability to interpret data from the study.

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 RATE

Outcome Description:

Complete response (CR/CRu) rate at 120 weeks 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.

Outcome Time Frame:

Timeframe: CR/CRu rate at 120 weeks

Safety Issue:

No

Principal Investigator

Franck Morschhauser, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

The Lymphoma Study Association (LYSA)

Authority:

United States: Food and Drug Administration

Study ID:

RV-FOL-GELARC-0683

NCT ID:

NCT01650701

Start Date:

February 2012

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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