MedTrace Logo

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

NCT01865110 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 623

Last updated 2025-03-05

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

R-CHOP

R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles

DRUG

R-CHOP / R-HAD

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

DRUG

Rituximab

Rituximab SC 1400 mg every 8 weeks for 24 months

DRUG

Lenalidomide

Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months

Sponsors & Collaborators

  • The Lymphoma Academic Research Organisation

    lead OTHER

Principal Investigators

  • Martin Dreyling, Prof. Dr. · MCL Network

  • Vincent Ribrag, Dr · Lymphoma Study Association

  • Johanna Cornelia Kluin-Nelemans, Prof. Dr. · MCL Network

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2020-11-30
Completion
2025-01-31

Countries

  • Belgium
  • France
  • Germany
  • Netherlands
  • Poland
  • Portugal
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865110 on ClinicalTrials.gov