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| Name | Class |
|---|---|
| Deutsche Krebshilfe e.V., Bonn (Germany) | OTHER |
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According to amendment 3 this study addresses the question if intensification of administration of rituximab in standard treatment for patients with newly diagnosed aggressive B-Non Hodgkin Lymphoma (B-NHL) and high risk (aaIPI 2 or 3) results in a better time to treatment failure (TTTF)
This study was primarily designed to compare aggressive conventional chemotherapy with a repetitive high-dose (HD) therapy program using identical, effective drugs at highest possible dose and dose intensity with/without addition of rituximab (initially 4 treatment arms). In 2004 the first amendment had to be added in order to close two treatment arms without rituximab due to recent data revealing a significant advantage for rituximab-treated patients with CD20+lymphoma.
A planned interim analysis in 2010 revealed inferiority of the high-dose treatment thus in the 2nd amendment the high-dose arm was closed and additionally the rituximab frequency was raised from 6 to 12 administrations as recent publications gave hint for advantage. The last amendment was added in 2010 to adjust for delayed recruitment mainly due to organisation problems.
As the high-dose arm was closed only CD20+ B-lymphoma were included past amendment 2.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| R-CHOEP14 with 12x Rituximab | Experimental | 8 cycles of standard CHOP with etoposide in 14-day intervals. Patients with CD20+ lymphoma receive 12 doses of Rituximab (day 0,1,4,8 of cycle 1, day 1 and 8 of cycle 2, day1 of cycle 3-8 ) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| R-CHOEP 14 with 12x Rituximab | Drug | after amendment 3 patients receive 4x 375mg/m2 in cycle 1 (day 0,1,4,8), 2x 375/m2 in cycle 2 (day1,8) and 1x 375mg/m2 cycle 3-8 (day 1 of each cycle) |
| Measure | Description | Time Frame |
|---|---|---|
| time to treatment failure | At 3 year follow up rate of treatments and time to treatment failure will be determined | 3 years after study inclusion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norbert Schmitz, Prof. | German High-Grade Non-Hodgkin's Lymphoma Study Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AK St. Georg | Hamburg | 20099 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38538861 | Derived | Oertel M, Ziepert M, Frontzek F, Nacke N, Altmann B, Nickelsen M, Glass B, Poeschel V, Ruebe C, Lenz G, Schmitz N, Eich HT. Radiotherapy in younger patients with advanced aggressive B-cell lymphoma-long-term results from the phase 3 R-MegaCHOEP trial. Leukemia. 2024 May;38(5):1099-1106. doi: 10.1038/s41375-024-02231-9. Epub 2024 Mar 27. | |
| 33667420 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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|
| Frontzek F, Ziepert M, Nickelsen M, Altmann B, Glass B, Haenel M, Truemper L, Held G, Bentz M, Borchmann P, Dreyling M, Viardot A, Kroschinsky FP, Metzner B, Staiger AM, Horn H, Ott G, Rosenwald A, Loeffler M, Lenz G, Schmitz N. Rituximab plus high-dose chemotherapy (MegaCHOEP) or conventional chemotherapy (CHOEP-14) in young, high-risk patients with aggressive B-cell lymphoma: 10-year follow-up of a randomised, open-label, phase 3 trial. Lancet Haematol. 2021 Apr;8(4):e267-e277. doi: 10.1016/S2352-3026(21)00022-3. Epub 2021 Mar 2. |
| 23168367 | Derived | Schmitz N, Nickelsen M, Ziepert M, Haenel M, Borchmann P, Schmidt C, Viardot A, Bentz M, Peter N, Ehninger G, Doelken G, Ruebe C, Truemper L, Rosenwald A, Pfreundschuh M, Loeffler M, Glass B; German High-Grade Lymphoma Study Group (DSHNHL). Conventional chemotherapy (CHOEP-14) with rituximab or high-dose chemotherapy (MegaCHOEP) with rituximab for young, high-risk patients with aggressive B-cell lymphoma: an open-label, randomised, phase 3 trial (DSHNHL 2002-1). Lancet Oncol. 2012 Dec;13(12):1250-9. doi: 10.1016/S1470-2045(12)70481-3. Epub 2012 Nov 16. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |