Allo-hNHL (FluBuCy)

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

DSHNHL R3 is a randomized clinical phase II study. The main objective is to estimate the efficacy of rituximab as a prophylactic medication for prevention of graft-versus-host-disease after allogeneic peripheral stem cell transplantation in patients with a high risk relapse of aggressive B-cell Non-Hodgkin's lymphoma. The most important secondary objective is to estimate the efficacy of allogeneic stem cell transplantation in this clinical situation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
• Collaborators: German High-Grade Non-Hodgkin's Lymphoma Study Group; University Hospital Goettingen
• Treatments: Rituximab; Tacrolimus

Criteria

Inclusion Criteria:

• histology proven aggressive non Hodgkin's lymphoma and

• primary progressive disease or

• early relapse after less than 12 month of remission duration and at least one risk factor according to the international prognostic index (IPI or

• relapse or progression after high dose chemotherapy and autologous transplantation or

• relapse or progression and lack of an autologous stem cell product.

Exclusion Criteria:

• severe comorbidity or impaired organ function

• hypersensitivity to used drugs

• HIV positivity

• active hepatitis

• other active malignant disease