Phase III, Randomized Trial: Lenalidomide vs Observation After Induction With Rituximab Followed by Cht and ASCT in MCL Adult Patients (MCL0208)
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|ClinicalTrials.gov Identifier: NCT02354313|
Recruitment Status : Active, not recruiting
First Posted : February 3, 2015
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|MANTLE CELL LYMPHOMA||Drug: Lenalidomide||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase III Multicenter, Randomized Study With Lenalidomide Maintenance vs Observation After Induction Regimen Containing Rituximab Followed by High Dose Chemotherapy and ASCT as First Line Treatment in Adult Patients With Advanced Mantle Cell Lymphoma|
|Actual Study Start Date :||May 2010|
|Actual Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2019|
lenalidomide 10-15 mg once daily on days 1-21, every 28 day, for two years
Treatment Phase: consisting in an induction phase (3 cycles of RCHOP, given every 21 days); consolidation phase: (high-dose cyclophosphamide (CTX), 2 cycles of high dose Ara-C, BEAM and ASCT).
Randomization and maintenance phase: Patients who have achieved complete or partial response will be randomized between maintenance with lenalidomide or observation.
Other Name: Revlimid
No Intervention: Observation
no therapy is planned but only observation
- Progression Free Survival (PFS) [ Time Frame: 30 months from randomisation ]PFS will be defined as the time between the date of randomization and the date of disease progression, relapse or death from any cause.therapy to prolong progression-free survival (PFS) after completion of first-line high-dose chemotherapy additioned with rituximab and followed by ASCT in adult patients with MCL who have achieved complete response (CR) or partial response (PR). PFS is defined according to Cheson et al (JCO, 2007) as the time from randomisation until lymphoma progression or death as a result of any cause.
- Overall Survival (OS) [ Time Frame: 36 months from randomisation (42 months from accrual) ]OS will be defined as the time between the date of randomization and the date of death from any cause
- Progression Free Survival (PFS) [ Time Frame: 36 months from accrual ]PFS will be defined as the time between the date of enrolment and the date of disease progression, relapse or death from any cause.
- Disease-free survival (DFS) [ Time Frame: 30 months from randomisation (36 months from accrual) ]DFS will be defined in CR patients as the time between the date of randomization and the date of relapse or death as a result of lymphoma or acute toxicity of treatment according to the Cheson 2007
- Event-free survival (EFS) [ Time Frame: 30 months from randomisation (36 months from accrual) ]EFS will be defined in CR patients as the time between the date of randomization and the date of failure of treatment or death as a result of any cause according to the Cheson 2007
- Complete Response (CR) Rate [ Time Frame: up to 3 months from accrual ]Proportion of CR according to the Cheson 2007 response criteria
- Overall Response Rate (ORR) [ Time Frame: up to 3 months from accrual ]ORR is defined as Complete Response (CR) or Partial Response (PR) according to the Cheson 2007 response criteria
- Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 at any time during therapy and follow-up. [ Time Frame: 30 months from accrual ]Toxicity amount of grade 3 or more as CTCAE
- Quality of life [ Time Frame: baseline, 6-12-18-24 months from randomisation ]EORTC QLQC30 questionnaire
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): NCT02354313
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|Study Director:||Sergio Cortelazzo, MD||Humanitas Gavazzeni - Bergamo, Lombardia|