Status: Closed
Activation Date: 2003AUG07
Closing Date: 2012DEC31
Phase: III
Description: A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared to Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R) -GDP VS (R) -DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin's Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab Versus Observation.
Eligibility: Patients to be included are those with a diagnosis of aggressive histology (B cell or T cell) non-Hodgkin's lymphoma whose disease is refractory to or relapsed after one prior first-line, anthracycline-containing chemotherapy regimen. Patients with CD20+ve B cell disease will be further evaluated after completion of protocol salvage treatment and autologous stem cell transplant (ASCT) for randomization to either maintenance rituximab or observation alone.
Objective: Randomization 1, Salvage Treatment [(R)-GDP vs (R)DHAP]. Primary: to compare response rates between the two salvage groups after two cycles of either (R)-GDP or (R)-DHAP; to compare the transplntation rate of the two salvage regimens. Secondary: to compare between the two arms event-free survival and overall survival, successful mobilization rates, quality of life, toxic effects, resource utilization, and medical/societal costs. Randomization 2, Maintenance (rituximab vs observation). Primary: to compare two-year event-free survival between the two maintenance groups. Secondary: to compare between the two arms two-year overall survival and toxic effects.
Participation: Not limited.
Lay Description: Chemotherapy that is given for non-Hodgkin's lymphoma when it has come back after previous treatment is called "salvage" chemotherapy. Depending on how well the lymphoma responds to salvage chemotherapy, a stem cell harvest and transplant might be done afterward. This research is being done because even when lymphoma goes away or gets better with salvage chemotherapy and stem cell harvest, it is important to find ways to keep it from coming back or getting worse after those treatments are completed. Rituximab has not been approved for this specific use by Health Canada or the U.S. Food and Drug Administration.
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Hide Tissue Samples
| Disease Site | Trial Code | Patients Accrued | Patients - Blocks | Patients - Slides | Patients - Blocks and/or Slides |
| HEMATOLOGIC | LY12 | 619 | 306 | 312 | 395 |
(Core size is 0.6 mm)
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Fluid Samples| Disease Site | Trial Code | Patients Accrued | TMA Blocks | Patients on TMA Blocks |
| HEMATOLOGIC | LY12 | 619 | 8 | 163 |
| 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 | LY12 | 619 | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 |