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Sponsored by: |
Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH |
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Information provided by: | Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH |
ClinicalTrials.gov Identifier: | NCT00521560 |
Phase II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy with simultaneous application of Zevalin and BEAM followed by autologous peripheral stem cell transplantation in relapsed and refractory CD 20+ Non-Hodgkin's lymphoma
Condition | Intervention | Phase |
---|---|---|
Primary Non-Hodgkin-Lymphoma Refractory Non-Hodgkin-Lymphoma CD20+ Aggressive Non-Hodgkin`s Lymphoma |
Drug: Zevalin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase I/II Study Concomitant High-Dose Radio-Immuno- and Chemotherapy With Simultaneous Application of Zevalin and BEAM Followed by Autologous Peripheral Stem Cell Transplantation in Relapsed and Refractory CD 20+ Non-Hodgkin's Lymphoma |
Estimated Enrollment: | 30 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | August 2014 |
Estimated Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: Zevalin
All applications of 90Y-Ibritumomab-Tiuxetan will be preceded by rituximab infusions at a dose of 250 mg/m2 at days -21 and day -14 (DL1) or day -12 (DL2) or day -10 (DL3-5), respectively. High dose therapy will be given as BEAM |
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
B-NHL:
Grade III B follicular lymphoma Diffuse B-cell lymphoma centroblastic immunoblastic plasmoblastic anaplastic-large-cell T-cell rich B-cell lymphoma Primary effusion lymphoma Intravascular B-cell lymphoma Primary mediastinal B-cell lymphoma Mantle cell lymphoma, blastoid Variants of Burkitt's lymphoma Aggressive marginal zone lymphoma (monocytoid)
Exclusion Criteria:
Contact: Bertram Glass, Prof. Dr. | ++49-40-1818853537 | b.glass@asklepios.com |
Germany | |
Institut für anwendungsorientierte Forschung und klinische Studien (IFS gGmbH) | Recruiting |
Göttingen, Germany, 37075 | |
Contact: Bertram Glass, MD, PhD ++49-40-1818853537 b.glass@asklepios.com | |
Contact: Alexander Berg ++49-551-3913497 berg.ifs@med.uni-goettingen.de |
Study Director: | Bertram Glass, Prof. Dr. | German Society of Cancer e.V. |
Principal Investigator: | Martin Gramatzki, MD PhD | Städtisches Krankenhaus Kiel, II. Med. Uniklinik, Kiel, Germany |
Principal Investigator: | Mattias Witzens Harig, MD PhD | Abteilung Innere Medizin V, Hämatologie, Onkologie, Heidelberg, Germany |
Principal Investigator: | Bernd Hertenstein, MD PhD | Klinikum Bremen-Mitte gGmbH, Medizinische Klinik I, Bremen, Germany |
Principal Investigator: | Georg Heß, MD PhD | III Med., Schwerpunkt Hämatologie / Onkologie, Mainz, Germany |
Principal Investigator: | Dorothea Kofahl-Krause, MD PhD | MHH, Hämatologie, Hämostaseologie und Onkologie, Hannover, Germany |
Principal Investigator: | Norbert Schmitz, MD PhD | Asklepios Klinik St. Georg, Hämatologische Abt., Hamburg, Germany |
Principal Investigator: | Jörg Schubert, MD PhD | Universitätskliniken d. Saarlandes, Med. I, Homburg/Saar, Germany |
Principal Investigator: | Lutz Uharek Uharek, MD PhD | Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany |
Responsible Party: | Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH ( Bertram Glass, MD, PhD ) |
Study ID Numbers: | DSHNHL 2004-R4, DSHNHL 2004-R4 |
Study First Received: | August 27, 2007 |
Last Updated: | March 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00521560 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices; Germany: Federal Office for Radiation Protection; Germany: Paul-Ehrlich-Institut |
High-Dose Radio-Immuno- and Chemotherapy stem cell transplantation 90Y-Ibritumomab-Tiuxetan |
Antibodies, Monoclonal Lymphatic Diseases Antibodies Immunoproliferative Disorders Rituximab Lymphoma, small cleaved-cell, diffuse |
Lymphoproliferative Disorders Aggression Lymphoma, Non-Hodgkin Lymphoma Immunoglobulins Behavioral Symptoms |
Neoplasms Neoplasms by Histologic Type Immunologic Factors |
Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |