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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01650701
Registration number
NCT01650701
Ethics application status
Date submitted
24/07/2012
Date registered
26/07/2012
Date last updated
15/03/2024
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
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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.
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Secondary ID [1]
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2011-002792-42
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Secondary ID [2]
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RV-FOL-GELARC-0683
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Universal Trial Number (UTN)
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Trial acronym
RELEVANCE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Follicular Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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COMPLETE RESPONSE RATE
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Assessment method [1]
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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.
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Timepoint [1]
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Timeframe: CR/CRu rate at 120 weeks
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Primary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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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.
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Timepoint [2]
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up to 13 years
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Secondary outcome [1]
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Number of participants with adverse events
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Assessment method [1]
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Timepoint [1]
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up to13 years
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Secondary outcome [2]
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Time to Treatment Failure (TTF)
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Assessment method [2]
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Timepoint [2]
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up to13 years
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Secondary outcome [3]
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Event Free Survival (EFS)
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Assessment method [3]
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Timepoint [3]
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up to13 years
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Secondary outcome [4]
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Time to Next Anti-Lymphoma Treatment (TTNLT),
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Assessment method [4]
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Timepoint [4]
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up to13 years
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Secondary outcome [5]
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Time to Next Chemotherapy Treatment (TTNCT)
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Assessment method [5]
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Timepoint [5]
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up to13 years
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Secondary outcome [6]
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Overall Survival (OS)
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Assessment method [6]
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Timepoint [6]
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up to13 years
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Secondary outcome [7]
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Overall response rate at 120 weeks by International Working Group (IWG) 1999 criteria
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Assessment method [7]
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Timepoint [7]
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up to13 years
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Secondary outcome [8]
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Health related quality of life as measured by the EORTC QLQ-C30
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Assessment method [8]
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Timepoint [8]
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up to13 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
1030
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Concord Repatriation General Hospital - Concord
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Recruitment hospital [2]
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Nepean Hospital - Penrith
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Recruitment hospital [3]
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Wollongong Hospital - Wollongong
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Recruitment postcode(s) [1]
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- Concord
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Recruitment postcode(s) [2]
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- Penrith
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Recruitment postcode(s) [3]
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- Wollongong
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Recruitment outside Australia
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Belgium
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State/province [1]
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Yvoir
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Canada
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State/province [2]
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Alberta
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Canada
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State/province [3]
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British Columbia
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Country [4]
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Canada
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State/province [4]
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New Brunswick
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Country [5]
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Canada
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State/province [5]
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Nova Scotia
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Country [6]
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Canada
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State/province [6]
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Ontario
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Country [7]
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Canada
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State/province [7]
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Quebec
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Country [8]
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Canada
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State/province [8]
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Saskatchewan
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Country [9]
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France
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State/province [9]
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Lille
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Country [10]
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Germany
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State/province [10]
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Baden Wurtemberg
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Germany
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State/province [11]
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Nordrhein
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Germany
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State/province [12]
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Munchen
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Italy
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State/province [13]
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Lazio
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Italy
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State/province [14]
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Bologna
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Country [15]
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Portugal
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State/province [15]
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Lisboa
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Country [16]
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Spain
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State/province [16]
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Andaloucia
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Spain
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State/province [17]
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Barcelona
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Spain
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Canarias
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Spain
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Mallorca
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Spain
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Girona
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Spain
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Madrid
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Spain
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Marbella
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Spain
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Salamanca
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Spain
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Valencia
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Lymphoma Academic Research Organisation
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Address
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Other collaborator category [1]
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Commercial sector/Industry
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Name [1]
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Celgene Corporation
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Address [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01650701
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Franck Morschhauser, MD, PhD
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Address
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The Lymphoma Study Association (LYSA)
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01650701
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