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Sponsored by: |
South West German Cancer Center |
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Information provided by: | South West German Cancer Center |
ClinicalTrials.gov Identifier: | NCT00302757 |
The study evaluates the additional use of radioimmunotherapy with a 90-Yttrium labeled monoclonal antibody targeting lymphoma cells in two dose reduced conditioning regimens for allogeneic hematopoietic cell transplantation from human leukocyte antigen (HLA)-identical donors. Radioimmunotherapy should allow an increased anti-lymphoma effect of the conditioning while the allogeneic grafts may confer potent graft versus lymphoma effects and rescue from potential hematopoietic side effects of the radioimmunotherapy. The study evaluates the feasibility and toxicity of such approach and will also analyze disease response and survival of the patients treated.
Condition | Intervention | Phase |
---|---|---|
Non-Hodgkin Lymphoma |
Drug: Radioimmunotherapy Procedure: allogeneic hematopoietic cell transplantation |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Multicenter Phase I/II Study of Radioimmunotherapy With 90Y-Ibritumomab Tiuxetan in a Nonmyeloablative Conditioning Regimen for Allogeneic Hematopoietic Cell Transplantation From HLA-Identical Donors in Patients With Advanced Non-Hodgkin Lymphoma |
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The following entities of lymphomas can be included in Arm A of the protocol:
Arm A:
Marginal zone lymphoma (MZL)
The following lymphoma entities can be included in Arm B of the protocol:
Arm B:
Mediastinal B-cell lymphoma
Exclusion Criteria:
Germany | |
South West German Cancer Center, University of Tuebingen Medical Center | |
Tuebingen, Germany, 72076 | |
University of Dresden Medical Center | |
Dresden, Germany, D-01307 | |
University of Wuerzburg Medical Center | |
Wuerzburg, Germany, D-97070 | |
Medical Center University of Leipzig | |
Leipzig, Germany, 04103 | |
Medical Center University of Hannover | |
Hannover, Germany, 30625 | |
Medical Center University of Ulm | |
Ulm, Germany, 89081 | |
Medical Center University of Goettingen | |
Goettingen, Germany, 37099 | |
Medical Center Charite Benjamin Franklin | |
Berlin, Germany, 12200 | |
Center for Marrow Transplantation, University of Essen | |
Essen, Germany, 45122 | |
Medical Center University of Muenster | |
Muenster, Germany, 48149 | |
Stiftung Deutsche Klinik für Diagnostik GmbH | |
Wiesbaden, Germany, 65191 | |
United Kingdom | |
The Royal Free and University College London Medical School London | |
London, United Kingdom, WC1E 6HX |
Principal Investigator: | Wolfgang A Bethge, MD | Medical Center University of Tuebingen |
Principal Investigator: | Donald Bunjes, MD | Medical Center University of Ulm |
Study ID Numbers: | 2005-002206-37 |
Study First Received: | March 10, 2006 |
Last Updated: | September 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00302757 |
Health Authority: | Germany: Paul-Ehrlich-Institut |
NHL low and high grade non-Hodgkin lymphoma |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |