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 (RELEVANCE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01650701 |
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Recruitment Status :
Active, not recruiting
First Posted : July 26, 2012
Last Update Posted : March 15, 2024
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Sponsor:
The Lymphoma Academic Research Organisation
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
The Lymphoma Academic Research Organisation
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Brief Summary:
The purpose of this study is to find out if lenalidomide when given along with rituximab can help to control the disease and also increase the length of your response (complete or partial response) compared to the standard of care rituximab chemotherapy treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Follicular Lymphoma | Drug: Rituximab Drug: Lenalidomide Drug: Rituximab - CHOP Drug: Rituximab - CVP Drug: Rituximab - Bendamustine | Phase 3 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1030 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 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. |
| Actual Study Start Date : | February 2012 |
| Actual Primary Completion Date : | May 31, 2017 |
| Estimated Study Completion Date : | April 2024 |
| Arm | Intervention/treatment |
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Experimental: Lenalidomide + Rituximab
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Drug: Rituximab
• 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.
Other Names:
Drug: Lenalidomide • Lenalidomide dose 20-mg on days 2-22 every 28 days x 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 upto 18 cycles
Other Name: Revlimid |
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Active Comparator: Control
• 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.
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Drug: Rituximab - CHOP
six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles Drug: Rituximab - CVP eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles, Drug: Rituximab - Bendamustine six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles. |
Primary Outcome Measures :
- COMPLETE RESPONSE RATE [ Time Frame: Timeframe: CR/CRu rate at 120 weeks ]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.
- Progression Free Survival (PFS) [ Time Frame: up to 13 years ]PFS is defined as the time from the start of study drug therapy to the 1st observation of disease progression or death due to any cause.
Secondary Outcome Measures :
- Number of participants with adverse events [ Time Frame: up to13 years ]
- Time to Treatment Failure (TTF) [ Time Frame: up to13 years ]
- Event Free Survival (EFS) [ Time Frame: up to13 years ]
- Time to Next Anti-Lymphoma Treatment (TTNLT), [ Time Frame: up to13 years ]
- Time to Next Chemotherapy Treatment (TTNCT) [ Time Frame: up to13 years ]
- Overall Survival (OS) [ Time Frame: up to13 years ]
- Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria [ Time Frame: up to13 years ]
- Health related quality of life as measured by the EORTC QLQ-C30 [ Time Frame: up to13 years ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01650701
Locations
Show 35 study locations
Sponsors and Collaborators
The Lymphoma Academic Research Organisation
Celgene Corporation
Investigators
| Study Chair: | Franck Morschhauser, MD, PhD | The Lymphoma Study Association (LYSA) |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | The Lymphoma Academic Research Organisation |
| ClinicalTrials.gov Identifier: | NCT01650701 |
| Other Study ID Numbers: |
RV-FOL-GELARC-0683 2011-002792-42 ( EudraCT Number ) |
| First Posted: | July 26, 2012 Key Record Dates |
| Last Update Posted: | March 15, 2024 |
| Last Verified: | March 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by The Lymphoma Academic Research Organisation:
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follicular lymphoma non-hodgkins follicular lymphoma treatment for follicular lymphoma rituximab treatment rituximab and lenalidomide treatment |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin Rituximab Lenalidomide Bendamustine Hydrochloride |
Antineoplastic Agents, Immunological Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action |