Status:
UNKNOWN
Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL
Lead Sponsor:
European Mantle Cell Lymphoma Network
Collaborating Sponsors:
German Low Grade Lymphoma Study Group
Lymphoma Study Association
Conditions:
Lymphoma, Mantle-Cell
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief 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 lymphom...
Detailed Description
This study investigates two independent questions in the treatment of elderly patients with mantle cell lymphomas: 1. To test in elderly patients with advanced mantle cell lymphoma, whether rituximab...
Eligibility Criteria
Inclusion
- Histologically proven mantle cell lymphoma according to the World Health Organization (WHO) classification, preferably confirmed by central pathology review before entering the study
- Clinical stage II, III or IV
- Previously untreated patients
- Above the age of 65 years and older or patients at the age between 60 and 65, if not eligible for high dose chemotherapy
- WHO performance grade 0, 1 or 2
- Informed consent according to International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use/European Union Good Clinical Practice (ICH/EU GCP) and national/local regulations
- Measurable disease. If, for example only bone marrow (BM) infiltration, patients can only undergo a second randomization if a CR is obtained.
Exclusion
- WHO performance of 3 or more
- Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies
- Leukocytes \<2.0x 10\^9/l or thrombocytes \<100x 10\^9/l, unless clearly related to mantle cell lymphoma (MCL) bone marrow infiltration
- Patients previously treated for lymphoma
- Patients without measurable lesions; if, for example only bone marrow infiltration, patients may be included, but can only undergo a second randomization in case of a CR
- Patients with stage I disease
- Patients with central nervous system involvement
- Patients with a history of autoimmune hemolytic anaemia or autoimmune thrombocytopenia
- Patients with serious cardiac disease (uncontrolled arrhythmias, unstable angina, severe congestive heart failure)
- Patients with serious pulmonary, neurological, endocrinological or other disorder interfering with full dosing of CHOP or FC chemotherapy
- Liver enzymes \>3x normal or bilirubin \>2.5x normal (not due to lymphoma)
- Creatinine \>2x normal value, corrected for age and weight (not due to lymphoma)
- Patients with unresolved hepatitis B or C infection or known HIV positive infection
- Uncontrolled infection
- Patients with a serious depression that needed therapy within the last 5 years
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- Concomitant or previous malignancies other than basal cell or squamous cell skin cancer, in situ cervical cancer and other cancer for which the patient has been disease-free for at least 5 years
Key Trial Info
Start Date :
January 14 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
570 Patients enrolled
Trial Details
Trial ID
NCT00209209
Start Date
January 14 2004
End Date
December 1 2018
Last Update
March 7 2017
Active Locations (7)
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1
General University Hospital, 1St Department of Medicine
Prague, Czechia, CZ-12808
2
Nordic Lymphoma Group
Copenhagen, Denmark, DK-2100
3
Groupe D´Etudes des Lymphomes De l´Adulte (GELA)
Paris, France, F-75743
4
German Low Grade Study Group (Glsg)
Munich, Germany, D-81377