Efficacy of R-CHOP vs R-CHOP/R-DHAP in Untreated MCL

NCT00209222 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 360

Last updated 2012-09-10

No results posted yet for this study

Summary

The aim of this study is to determine whether alternating courses of cyclophosphamide, doxorubicin, vincristine, prednisone/dexamethasone, cytarabine, cisplatin (CHOP/DHAP) plus rituximab followed by total body irradiation \[TBI\]/high dose cytarabine \[ARA-C\]/melphalan-peripheral blood stem cell transplantation (TAM-PBSCT) can improve the time to treatment failure compared to CHOP plus rituximab followed by standard PBSCT (dexamethasone, carmustine, cytarabine, etoposide, and melphalan \[Dexa-BEAM\]/TBI/high dose cyclophosphamide) in patients with untreated mantle cell lymphoma.

Conditions

  • Lymphoma, Mantle-Cell

Interventions

DRUG

Rituximab

antibody

DRUG

Cyclophosphamide

chemotherapy

DRUG

Doxorubicin

chemotherapy

DRUG

Vincristine

chemotherapy

DRUG

Prednisone

corticosteroide

DRUG

Cisplatinum

chemotherapy

DRUG

Ara-C

chemotherapy

DRUG

Dexamethasone

corticosteroide

DRUG

BCNU

chemotherapy

DRUG

Melphalan

chemotherapy

DRUG

Etoposide

chemotherapy

DRUG

G-CSF

growth factor

PROCEDURE

chemotherapy: R-CHOP

immuno-chemotherapy

PROCEDURE

chemotherapy: R-DHAP

immuno-chemotherapy

PROCEDURE

chemotherapy: Dexa-BEAM

chemotherapy

PROCEDURE

stem cell harvest

procedure

PROCEDURE

total body irradiation

radiation

PROCEDURE

high-dose chemotherapy: Cyclophosphamide

chemotherapy

PROCEDURE

high-dose chemotherapy: Ara-C /Melphalan

chemotherapy

Sponsors & Collaborators

  • German Low Grade Lymphoma Study Group

    collaborator OTHER
  • Lymphoma Study Association

    collaborator OTHER
  • European Mantle Cell Lymphoma Network

    lead OTHER

Principal Investigators

  • Olivier Hermine, PhD · University Hospital Necker, Dept. of Adult Hematology

  • Wolfgang Hiddemann, PhD · University Hospital Großhadern/LMU, Dept. of Medicine III

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • France
  • Germany
  • Poland

Study Locations

More Related Trials

Entities

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 NCT00209222 on ClinicalTrials.gov