Status:
COMPLETED
Allo-hNHL (FluBuCy)
Lead Sponsor:
Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH
Collaborating Sponsors:
University Hospital Goettingen
German High-Grade Non-Hodgkin's Lymphoma Study Group
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Patients in the age of 18 to 65 years with a high- risk relapse of a histology proven aggressive Non-Hodgkin's-lymphoma are eligible for the trial. Aggressive Non-Hodgkin's lymphoma within this study ...
Eligibility Criteria
Inclusion
- 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
- severe comorbidity or impaired organ function
- hypersensitivity to used drugs
- HIV positivity
- active hepatitis
- other active malignant disease
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00785330
Start Date
April 1 2004
End Date
April 1 2011
Last Update
January 13 2020
Active Locations (6)
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1
Universitätsklinikum Heidelberg
Heidelberg, Baden-Würtenberg, Germany
2
Universitätsklinikum Marburg
Marburg, Hesse, Germany
3
Universitätsklinikum und Poliklinik
Homburg, Saarland, Germany
4
University Hospital Goettingen
Göttingen, Germany, D.37075