Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma

PHASE2CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 30, 2000

Primary Completion Date

March 31, 2005

Conditions
Lymphoma
Interventions
BIOLOGICAL

filgrastim

Beginning 36-48 hours after the completion of cyclophosphamide, patients receive filgrastim (G-CSF) subcutaneously (SC) daily until blood counts recover. Patients receive G-CSF SC daily beginning 4 hours after completion of PBSC infusion and continuing until neutrophil engraftment.

BIOLOGICAL

rituximab

rituximab IV over 2-5 hours on days 1, 8, and 15

DRUG

carmustine

After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3

DRUG

cisplatin

After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.

DRUG

cyclophosphamide

cyclophosphamide IV over 3-6 hours on day 16.

DRUG

etoposide

After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.

PROCEDURE

bone marrow ablation with stem cell support

Patients then undergo peripheral blood stem cell (PBSC) collection.

PROCEDURE

peripheral blood stem cell transplantation

Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.

RADIATION

radiation therapy

Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

Trial Locations (1)

44106-7284

Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00028665 - Cyclophosphamide W/or W/Out Rituximab and Peripheral Stem Cell Transplantation in Patients With Recurrent Non-Hodgkin's Lymphoma | Biotech Hunter | Biotech Hunter