R-CHOP + R-HAD vs R-CHOP Followed by Maintenance Lenalidomide + Rituximab vs Rituximab for Older Patients With MCL

Sponsor
The Lymphoma Academic Research Organisation
Study ID
NCT01865110
Phase
PHASE3
Status
Completed

Conditions

  • Mantle Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • R-CHOP — DRUG
    R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
  • R-CHOP / R-HAD — DRUG
    R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) administered in 3 week cycles for 3 cycles R-HAD (rituximab, cytarabine, dexamethasone) administered in 3 week cycles for 4 cycles alternating
  • Rituximab — DRUG
    Rituximab SC 1400 mg every 8 weeks for 24 months
  • Lenalidomide — DRUG
    Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months

Study Details

This study aims to evaluate whether the addition of lenalidomide to rituximab-maintenance improves progression free survival (PFS) compared to standard rituximab maintenance after induction treatment consisting of R-CHOP + R-HAD vs R-CHOP alone in older patients (≥ 60 year old) with mantle cell lymphoma. The treatments consist of two phases: induction treatment (3 R-CHOP21 + 3 cycles of R-HAD28 alternating) vs 8 cycles of R-CHOP21) followed by maintenance treatment (13 cycles of rituximab + 26 cycles of lenalidomide vs 13 cycles of rituximab).

Key Dates

Start date
Nov 30, 2013
Status verified
Mar 2025
Primary completion
Nov 30, 2020
Completion
Jan 31, 2025

Study Design

Enrollment
623 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Induction experimental arm
    R-CHOP / R-HAD : Alternating 3 cycles of R-CHOP administered in 3 week cycles + 3 cycles of R-HAD administered in 4 week cycles.
  • Active Comparator: Standart induction arm
    8 cycles of R-CHOP administered in 3 week cycles
  • Experimental: Maintenance experimental arm
    lenalidomide + rituximab : 13 cycles of rituximab SC 1400 mg administered in 8 week cycles + 26 cycles Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
  • Active Comparator: Maintenance standart arm
    13 cycles of rituximab SC 1400 mg administered in 8 week cycles for 24 months

Primary Outcome Measure

Progression free survival [ Time Frame: 2.5 years ]

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