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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01650701




Registration number
NCT01650701
Ethics application status
Date submitted
24/07/2012
Date registered
26/07/2012

Titles & IDs
Public 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
Scientific 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.
Secondary ID [1] 0 0
2011-002792-42
Secondary ID [2] 0 0
RV-FOL-GELARC-0683
Universal Trial Number (UTN)
Trial acronym
RELEVANCE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Lenalidomide
Treatment: Drugs - Rituximab - CHOP
Treatment: Drugs - Rituximab - CVP
Treatment: Drugs - Rituximab - Bendamustine

Experimental: Lenalidomide + Rituximab - * 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
* 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.

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.


Treatment: Drugs: 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.

Treatment: Drugs: 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

Treatment: Drugs: 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

Treatment: Drugs: 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,

Treatment: Drugs: 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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
COMPLETE RESPONSE RATE
Timepoint [1] 0 0
Timeframe: CR/CRu rate at 120 weeks
Primary outcome [2] 0 0
Progression Free Survival (PFS)
Timepoint [2] 0 0
up to 13 years
Secondary outcome [1] 0 0
Number of participants with adverse events
Timepoint [1] 0 0
up to13 years
Secondary outcome [2] 0 0
Time to Treatment Failure (TTF)
Timepoint [2] 0 0
up to13 years
Secondary outcome [3] 0 0
Event Free Survival (EFS)
Timepoint [3] 0 0
up to13 years
Secondary outcome [4] 0 0
Time to Next Anti-Lymphoma Treatment (TTNLT),
Timepoint [4] 0 0
up to13 years
Secondary outcome [5] 0 0
Time to Next Chemotherapy Treatment (TTNCT)
Timepoint [5] 0 0
up to13 years
Secondary outcome [6] 0 0
Overall Survival (OS)
Timepoint [6] 0 0
up to13 years
Secondary outcome [7] 0 0
Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria
Timepoint [7] 0 0
up to13 years
Secondary outcome [8] 0 0
Health related quality of life as measured by the EORTC QLQ-C30
Timepoint [8] 0 0
up to13 years

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2024
Actual
Sample size
Target
Accrual to date
Final
1030
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [2] 0 0
Nepean Hospital - Penrith
Recruitment hospital [3] 0 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 0 0
- Concord
Recruitment postcode(s) [2] 0 0
- Penrith
Recruitment postcode(s) [3] 0 0
- Wollongong
Recruitment outside Australia
Country [1] 0 0
Belgium
State/province [1] 0 0
Yvoir
Country [2] 0 0
Canada
State/province [2] 0 0
Alberta
Country [3] 0 0
Canada
State/province [3] 0 0
British Columbia
Country [4] 0 0
Canada
State/province [4] 0 0
New Brunswick
Country [5] 0 0
Canada
State/province [5] 0 0
Nova Scotia
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Canada
State/province [8] 0 0
Saskatchewan
Country [9] 0 0
France
State/province [9] 0 0
Lille
Country [10] 0 0
Germany
State/province [10] 0 0
Baden Wurtemberg
Country [11] 0 0
Germany
State/province [11] 0 0
Nordrhein
Country [12] 0 0
Germany
State/province [12] 0 0
Munchen
Country [13] 0 0
Italy
State/province [13] 0 0
Lazio
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Portugal
State/province [15] 0 0
Lisboa
Country [16] 0 0
Spain
State/province [16] 0 0
Andaloucia
Country [17] 0 0
Spain
State/province [17] 0 0
Barcelona
Country [18] 0 0
Spain
State/province [18] 0 0
Canarias
Country [19] 0 0
Spain
State/province [19] 0 0
Mallorca
Country [20] 0 0
Spain
State/province [20] 0 0
Girona
Country [21] 0 0
Spain
State/province [21] 0 0
Madrid
Country [22] 0 0
Spain
State/province [22] 0 0
Marbella
Country [23] 0 0
Spain
State/province [23] 0 0
Salamanca
Country [24] 0 0
Spain
State/province [24] 0 0
Valencia

Funding & Sponsors
Primary sponsor type
Other
Name
The Lymphoma Academic Research Organisation
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Celgene Corporation
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Franck Morschhauser, MD, PhD
Address 0 0
The Lymphoma Study Association (LYSA)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT01650701