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| ID | Type | Description | Link |
|---|---|---|---|
| DSHNHL 2004-R4 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zevalin | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variable is the highest achievable dose level of 90Y-Zevalin administered immediately before BEAM high-dose therapy and followed by autologous stem cell transplantation. | 3 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment related mortality (TRM), freedom from progression (FFP), Survival (OS), progression free survival (PFS) grade III -IV toxicity (CTC) on lung, liver and kidney | 3 Years |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Bertram Glass, Prof. Dr. | German Society of Cancer e.V. | Study Director |
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut für anwendungsorientierte Forschung und klinische Studien (IFS GmbH) | Göttingen | 37075 | Germany |
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|
| Charité - Campus Benjamin Franklin, Med. III, Berlin, Germany |
| Principal Investigator |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C422802 | ibritumomab tiuxetan |
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