Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma - Full Text View

Purpose

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.

Condition	Intervention	Phase
Follicular Lymphoma	Drug: Rituximab Drug: Lenalidomide Drug: Rituximab-CHOP Drug: Rituximab-CVP Drug: Rituximab-Bendamustine	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Bendamustine hydrochloride Bendamustine Rituximab Lenalidomide

U.S. FDA Resources

Further study details as provided by Celgene Corporation:

Primary Outcome Measures:

Complete response (CR/CRu) rate for Follicular Lymphoma [ Time Frame: 120 weeks ] [ Designated as safety issue: No ]
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%.
Progression free survival (PFS)Follicular lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Progression-free survival is defined as the time from the start of study drug therapy to the first observation of disease progression or death due to any cause.
Safety in Follicular lymphoma [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: Yes ]
Safety in Follicular lymphoma

Secondary Outcome Measures:

Number of participants with adverse events [ Time Frame: Up to 13 years ] [ Designated as safety issue: Yes ]
Time to Treatment Failure (TTF)Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Time to Treatment Failure (TTF)Follicular Lymphoma
Number of Participants who Survive without an Event(s) [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Event Free Survival (EFS)Follicular Lymphoma
Time to Next Anti-Lymphoma Treatment (TTNLT) for Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Time to Next Anti-Lymphoma Treatment (TTNLT) for Follicular Lymphoma
Time to Next Chemotherapy Treatment (TTNCT) for Follicular Lymphoma [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Time to Next Chemotherapy Treatment (TTNCT) for Follicular Lymphoma
Number of participants alive or dead [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Overall response by International Working Group (IWG) 1999 criteria [ Time Frame: Up to 120 weeks ] [ Designated as safety issue: No ]
Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients [ Time Frame: Up to 13 years ] [ Designated as safety issue: No ]
Health related quality of life as measured by the EORTC QLQ-C30 for Follicular Lymphoma patients

Estimated Enrollment:	1000
Study Start Date:	November 2011
Estimated Study Completion Date:	June 2024
Estimated Primary Completion Date:	June 2024 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lenalidomide + Rituximab Lenalidomide dose 20-mg on days 2-22 every 28 days for 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 up to 18 cycles. 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.	Drug: 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. Drug: Lenalidomide 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
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.	Drug: Rituximab-CHOP 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles. Drug: Rituximab-CVP 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles. Drug: Rituximab-Bendamustine 7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Arms

Assigned Interventions

Experimental: Lenalidomide + Rituximab

Lenalidomide dose 20-mg on days 2-22 every 28 days for 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 up to 18 cycles.
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.

Drug: 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.

Drug: Lenalidomide

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

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.

Drug: Rituximab-CHOP

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Drug: Rituximab-CVP

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Drug: Rituximab-Bendamustine

7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01476787

Contacts

Contact: Associate Director, Clinical Trial Disclosure	1-888-260-1599	clinicaltrialdisclosure@celgene.com
Contact: Christian Aeschlimann, MSc	+41 32 729 87 92	caeschlimann@celgene.com

Show 35 Study Locations

Sponsors and Collaborators

Celgene Corporation

The Lymphoma Academic Research Organisation

Investigators

Study Chair:

Nathan H Fowler, M.D.

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

More Information

No publications provided

Responsible Party:	Celgene Corporation
ClinicalTrials.gov Identifier:	NCT01476787 History of Changes
Other Study ID Numbers:	RV-FOL-GELARC-0683C, 2011-002792-42
Study First Received:	November 18, 2011
Last Updated:	January 17, 2013
Health Authority:	United States: Food and Drug Administration

Keywords provided by Celgene Corporation:

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

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Bendamustine
Rituximab
Lenalidomide
Thalidomide
Antineoplastic Agents

Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Immunosuppressive Agents
Leprostatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013

Combined Rituximab and Lenalidomide Treatment for Untreated Patients With Follicular Lymphoma (RELEVANCE)