Rituximab & Combination Chemotherapy Followed by Transplantation in Relapsed or Refractory Non-Hodgkin's Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

September 1, 2000

Primary Completion Date

January 1, 2002

Study Completion Date

January 1, 2011

Conditions
Lymphoma
Interventions
BIOLOGICAL

rituximab

Rituximab at 375 mg/m2 administered approximately one week apart prior to collection of the hematopoietic stem cells. Rituxan at a dose of 375 mg/m2 IV will be given either on the days prior to initiation of the BCNU (days -10 to -7) or on the same day that the BCNU is administered for the BEAM chemotherapy regimen (Day -6). A fourth infusion of Rituxan 375 mg/m2 will be given at 30 day (+/- 20 days) post-transplant. At approximately 6 months post-transplant, if the patients have not had progressive lymphoma, they will receive four weekly doses of Rituxan 375 mg/m2 IV.

DRUG

carmustine

BCNU 300 mg/M2 IV day -6

DRUG

cytarabine

100 mg/m2 on days -5 through -2

DRUG

etoposide

100mg/M2 BID on days -5 through -2

DRUG

melphalan

140 mg/m2 IV on day -1

PROCEDURE

autologous hematopoietic stem cell transplantation

Following the chemotherapy, on day 0 of treatment, the previously stored hematopoietic stem cells will be reinfused via the central venous line

Trial Locations (1)

68198

University of Nebraska Medical Center, Omaha

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

collaborator

Genentech, Inc.

INDUSTRY

lead

University of Nebraska

OTHER