Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL
NCT00209209 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 570
Last updated 2017-03-07
Summary
The aim of this study is to answer the following independent questions in the treatment of mantle cell lymphomas:
* Can rituximab-fludarabine, cyclophosphamide (R-FC) improve the reduction of lymphoma mass compared to rituximab-cyclophosphamide, doxorubicin, vincristine, prednisone (R-CHOP) and so become a new standard for initial cytoreductive therapy?
* Can maintenance with rituximab substitute the interferon maintenance and even improve the progression free survival in patients after successful initial cytoreductive therapy?
Conditions
- Lymphoma, Mantle-Cell
Interventions
- DRUG
-
antibody
- DRUG
-
chemotherapy
- DRUG
-
Doxorubicin
chemotherapy
- DRUG
-
Vincristine
chemotherapy
- DRUG
-
coricosteroide
- DRUG
-
chemotherapy
- DRUG
-
Interferon-alpha
cytokine
- DRUG
-
pegylated formula Interferon-alpha 2b
cytokine
- PROCEDURE
-
chemotherapy: R-CHOP
immuno-chemotherapy
- PROCEDURE
-
chemotherapy: R-FC
immuno-chemotherapy
- PROCEDURE
-
Interferon maintenance
cytokine
- PROCEDURE
-
Rituximab maintenance
antibody
Sponsors & Collaborators
-
German Low Grade Lymphoma Study Group
collaborator OTHER -
Lymphoma Study Association
collaborator OTHER -
HOVON - Dutch Haemato-Oncology Association
collaborator OTHER -
Nordic Lymphoma Group
collaborator NETWORK -
European Mantle Cell Lymphoma Network
lead OTHER
Principal Investigators
-
Hanneke C. Kluin-Nelemans, PhD · University Hospital Groningen, Dept. of Hematology
-
Martin Dreyling, PhD · University Hospital Grosshadern/LMU, Dept. of Medicine III
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-01-14
- Primary Completion
- 2018-12-31
- Completion
- 2018-12-31
Countries
- Czechia
- Denmark
- France
- Germany
- Italy
- Netherlands
- Poland
Study Locations
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