At a glance
ClinicalIndex Comparison Record- ✓Histologically confirmed aggressive non-Hodgkin's lymphoma: DLBCL (including primary mediastinal and T-cell-rich), transformed indolent lymphoma (e.g., follicular center cell, marginal zone, lymphoplasmacytoid), peripheral T-cell lymphoma, anaplastic large cell lymphoma, or small noncleaved Burkitt-like lymphoma
- ✓T-cell or B-cell lineage confirmed by immunohistochemistry
- ✓Measurable disease (≥1 bidimensionally measurable site: lymph nodes >1.5 cm, other lesions ≥1.0 cm) or evaluable disease only
- ✓Age 16-65 years
- ✕Uncontrolled CNS involvement by lymphoma; CNS disease at time of relapse not allowed (unless CNS disease at initial presentation with complete response and maintenance)
- ✕Prior high-dose chemotherapy with stem cell transplantation
- ✕Prior radiotherapy to more than 25% of functioning bone marrow
- ✕Pregnant or nursing
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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 vs Observation
In Brief
A Phase 3 clinical trial evaluating rituximab, cisplatin, and 3 other interventions for Lymphoma. Completed, enrolled 849 participants across 27 sites in 3 countries.
Detailed Summary
RATIONALE: Drugs used in chemotherapy, such as dexamethasone, cisplatin, gemcitabine, and cytarabine, work in different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with autologous stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. Monoclonal antibodies, such as rituximab, can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Giving rituximab as maintenance therapy after stem cell transplantation may kill any remaining cancer cells. It is not yet known which salvage chemotherapy regimen is more effective before autologous stem cell transplantation in treating relapsed or refractory non-Hodgkin's lymphoma. PURPOSE: This randomized phase III trial is studying salvage chemotherapy using dexamethasone, cisplatin, and gemcitabine to see how well it works compared to dexamethasone, cisplatin, and cytarabine given before autologous stem cell transplantation in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. This trial also is studying giving rituximab as maintenance therapy to see how well it works compared to no further therapy after stem cell transplantation. Rituximab was added to both salvage treatment arms for CD20+ patients in a protocol amendment in 2005.
Study Details
Timeline
Interventions
Given IV
Given IV
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Given IV