Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP (REMARC)
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|ClinicalTrials.gov Identifier: NCT01122472|
Recruitment Status : Active, not recruiting
First Posted : May 13, 2010
Last Update Posted : March 9, 2017
This study is designed as a phase III, randomized, double-blind, placebo-controlled trial to explore the effect of maintenance therapy with lenalidomide versus placebo on progression-free survival (PFS) in patients treated with R-CHOP responding to induction therapy
For the primary efficacy variable, PFS, an improvement in median PFS from 38.6 months for Treatment Arm B to 54 months for Treatment Arm A (corresponding to a 2-year PFS of 65% vs 73.6%), is considered clinically relevant.
|Condition or disease||Intervention/treatment||Phase|
|Lymphoma Diffuse Large B-cell Lymphoma||Drug: Lenalidomide Drug: Placebo||Phase 3|
Patients should have received at least 6 and up to 8 cycles of the R-CHOP 14 or R-CHOP 21 regimen or 6 R-CHOP-14 or -21 completed by 2 Rituximab alone in accordance to local preferences.
Patients can be registered to participate in the study at two time points:
- At time of initial diagnosis and study enrolment (signature of informed consent) before the first cycle of treatment with R-CHOP.
- At randomization (signature of informed consent) after treatment in first line with R-CHOP and have reached at least PR or CR.
Evaluation of the response to R-CHOP must be in accordance with Revised Response Criteria for Malignant Lymphoma(2007).
Stratification: Before randomization, the patients will be stratified according to the country and the response to R-CHOP (PR vs CR).
Randomization: Patients in CR/PR after R-CHOP will be randomized to maintenance therapy with lenalidomide or placebo.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||650 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double Blind Randomized Phase III Study of Lenalidomide Maintenance Versus Placebo in Responding Elderly Patients With DLBCL and Treated With R-CHOP in First Line|
|Study Start Date :||April 2009|
|Primary Completion Date :||June 2016|
|Estimated Study Completion Date :||September 2019|
Lenalidomide daily for 3 weeks every 4 weeks for 24 months
Daily for 3 weeks every 4 weeks for 24 months
Other Name: Revlimid
Placebo Comparator: Placebo
Placebo daily for 3 weeks every 4 weeks for 24 months
Daily for 3 weeks every 4 weeks for 24 months
- Progression-Free-Survival (PFS) [ Time Frame: Final PFS analysis will be realized when the number of events (160) has been reached or at the latest when the last patient into the study will finish follow up. The approximate schedule will be 75 months after the first patient randomized. ]PFS will be measured from the date of randomization to the date of first documented disease progression or death. Progression data will be assigned to the earliest time when any progression is observed without prior missing assessments during the study up to the end of the follow up phase.
- Overall survival (OS) [ Time Frame: 5 years ]From the date of randomization to the date of death from any cause Interim analysis of OS will be performed at the time of the PFS final analysis; it is projected to have 97 deaths at this time. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
- Event-Free Survival (EFS) [ Time Frame: 5 years ]From the date of randomization to the date of first documented disease progression, relapse, initiation of new anti-lymphoma therapy or death from any cause Interim analysis of EFS will be performed at the time of the PFS final analysis. Final analysis of OS at the end of the study, defined by the last visit of follow-up for the last patient randomized, 5 years after its randomization
- Response rate at the end of maintenance treatment [ Time Frame: 24 months ]
- Percentage of patients who convert from PR (partial response) to CR (complete response) [ Time Frame: 24 months ]
- Safety of lenalidomide in maintenance [ Time Frame: 5 years ]Toxicities occured during maintenance phase will be measured and reported from grade 2 for infection and neurological toxicities and from grade 3 for other toxicities according to CTCAE v3
- PFS2 [ Time Frame: 5 years ]From randomization to objective tumor progression on next-line treatment or death from any cause
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): NCT01122472
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|Principal Investigator:||Bertrand COIFFIER, Prof||The Lymphoma Study Association (LYSA)|