Chemotherapy Before Autologous Stem Cell Transplantation +/- Rituximab in Relapsed or Refractory Aggressive Non-Hodgkin's Lymphoma
Completed · Phase 3
Conditions studied: Lymphoma
In brief
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.
Key facts
- Study ID
- NCT00078949
- Run by
- NCIC Clinical Trials Group
- People needed
- 849
- Starts
- 2003-08-27
- Expected to finish
- 2018-12-01
- Last updated by the study team
- 2023-08-23
Who can join
Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Rush-Presbyterian-St. Luke's Medical Centre — Chicago, Illinois, United States
- Indiana University Medical Center — Indianapolis, Indiana, United States
- Hackensack University Medical Center — Hackensack, New Jersey, United States
- University of Cincinnati, Barrett Cancer Centre — Cincinnati, Ohio, United States
- University of Pittsburgh Cancer Institute — Pittsburgh, Pennsylvania, United States
- The Queen Elizabeth Hospital — Woodville, South Australia, Australia
- Tom Baker Cancer Centre — Calgary, Alberta, Canada
- Cross Cancer Institute — Edmonton, Alberta, Canada
- CancerCare Manitoba — Winnipeg, Manitoba, Canada
- The Moncton Hospital — Moncton, New Brunswick, Canada
- Dr. H. Bliss Murphy Cancer Centre — St. John's, Newfoundland and Labrador, Canada
- QEII Health Sciences Center — Halifax, Nova Scotia, Canada
- Juravinski Cancer Centre at Hamilton Health Sciences — Hamilton, Ontario, Canada
- Cancer Centre of Southeastern Ontario at Kingston — Kingston, Ontario, Canada
- London Regional Cancer Program — London, Ontario, Canada
- Credit Valley Hospital — Mississauga, Ontario, Canada
- Thunder Bay Regional Health Science Centre — Thunder Bay, Ontario, Canada
- Odette Cancer Centre — Toronto, Ontario, Canada
- St. Michael's Hospital — Toronto, Ontario, Canada
- Univ. Health Network-Princess Margaret Hospital — Toronto, Ontario, Canada
- Hopital Charles LeMoyne — Greenfield Park, Quebec, Canada
- CHUM - Hopital Notre-Dame — Montreal, Quebec, Canada
- CHUQ-Pavillon Hotel-Dieu de Quebec — Québec, Quebec, Canada
- CHA-Hopital Du St-Sacrement — Québec, Quebec, Canada
- Centre hospitalier universitaire de Sherbrooke — Sherbrooke, Quebec, Canada
Full record on ClinicalTrials.gov
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