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
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.
View this trial on ClinicalTrials.gov
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