Induction Chemotherapy (R-CHOP Vs. R-FC) Followed by Interferon Maintenance Versus Rituximab Maintenance in MCL

• Status: Unknown status
• Trial end date: 2018-12-01
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: European Mantle Cell Lymphoma Network
• Collaborators: German Low Grade Lymphoma Study Group; HOVON - Dutch Haemato-Oncology Association; Lymphoma Study Association; Nordic Lymphoma Group
• Treatments: Cyclophosphamide; Doxorubicin; Fludarabine; Interferon alpha-2; Interferon-alpha; Interferons; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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