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
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
-
antibody
- DRUG
-
chemotherapy
- DRUG
-
Doxorubicin
chemotherapy
- DRUG
-
Vincristine
chemotherapy
- DRUG
-
corticosteroide
- DRUG
-
Cisplatinum
chemotherapy
- DRUG
-
Ara-C
chemotherapy
- DRUG
-
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
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