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

• Status: Unknown status
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: European Mantle Cell Lymphoma Network
• Collaborators: German Low Grade Lymphoma Study Group; Lymphoma Study Association
• Treatments: Cisplatin; Cyclophosphamide; Cytarabine; Dexamethasone; Doxorubicin; Etoposide; Melphalan; Prednisone; Rituximab; Vincristine

Criteria

Inclusion Criteria:

• Histologically proven diagnosis of mantle cell lymphoma (World Health Organization [WHO] classification)

• Clinical stage II - IV (Ann Arbor)

• Previously untreated patients

• Age 18 - 65 years

• WHO performance < 2

• Measurable disease (also: patients with isolated bone marrow involvement)

• 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

Exclusion Criteria:

• Age > 65 years

• WHO performance status > 2

• Known anti-murine antibody (HAMA) reactivity or known hypersensitivity to murine antibodies

• Previous lymphoma therapy with radiation, cytostatic drugs, anti-CD20 antibody or interferon

• Serious disease interfering with a regular therapy according to the study protocol:

• cardiac (e.g. manifest heart failure, coronary heart disease, uncontrolled hypertension)

• pulmonary (e.g. chronic lung disease with hypoxemia)

• endocrine (e.g. severe, not sufficiently controlled diabetes mellitus)

• renal insufficiency (unless caused by the lymphoma): creatinine > 2x normal value and/or creatinine clearance < 50 ml/min)

• impairment of liver function (unless caused by the lymphoma): transaminases > 3x normal or bilirubin > 2,0 mg/dl

• Patients with unresolved hepatitis B or C infection or known HIV infection

• Prior organ, bone marrow or peripheral blood stem cell transplantation

• Concomitant or previous malignancies within the last 5 years other than basal cell skin cancer or in situ uterine cervix cancer.

• Pregnancy or lactation

• Any psychological, familiar, sociological, or geographical condition potentially hampering compliance with the study protocol and follow up schedule