Status: Closed
Activation Date: 2001NOV28
Closing Date: 2007DEC15
Phase: III
Description: A Randomized Phase III Trial Comparing Early High Dose Chemoradiotherapy and an Autologous Stem Cell Transplant to Conventional Dose CHOP Chemotherapy Plus Rituximab for CD20+B-Cell Lymphomas (With Possible Late Autologous Stem Cell Transplant)for Patients With Diffuse Aggressive Non-Hodgkin's Lymphoma in the High-Intermediate/High Risk International Classification Prognostic Groups
Eligibility: Patients must have biopsy proven intermediate or high grade non-Hodgkin's lymphoma (Working Formulation groups D through H and J) except lymphoblastic lymphoma (Working Formulation group I). Transformed lymphomas are not eligible. Mantle cell lymphomas are considered to be Working Formulation group E, but are ineligible for this study.
Objective: To compare in a cooperative group setting the overall survival and progression free survival of patients in the age adjusted High-Intermediate and High Risk Prognostic Groups of the International Classification with diffuse aggressive non-Hodgkin?s lymphomas who are treated on a randomized trial that compares standard conventional chemotherapy to an abbreviated course of induction chemotherapy followed by early transplantation. To compare the toxicity of these treatment strategies.
Participation: Open to member centres
Lay Description: The purpose of this study is to compare the effects (good and bad) on this lymphoma of a combination of treatments (induction chemotherapy, followed by high-dose chemotherapy with or without radiation, followed by stem cell infusion) to the standard treatment. The combination of treatments (chemotherapy followed by high-dose chemotherapy and stem cell infusion) has not been used to treat a large number of patients with this kind of cancer.
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Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
HEMATOLOGIC | LY11 | 122 | 4 | 14 | 15 |
(Core size is 0.6 mm)
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Fluid SamplesDisease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
HEMATOLOGIC | LY11 | 122 | 0 | 0 |
Disease Site | Trial Code | Patients Accrued | Patients - Whole Blood | Patients - Cellular Component of Blood | Patients - DNA extracted from Blood | Patients - RNA extracted from Blood | Patients - Plasma | Patients - Serum | Patients - Urine | Patients - Buccal |
HEMATOLOGIC | LY11 | 122 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |