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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
Case Comprehensive Cancer Center
Study ID
NCT00028665
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
    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.
  • rituximab — BIOLOGICAL
    rituximab IV over 2-5 hours on days 1, 8, and 15
  • carmustine — DRUG
    After completion of PBSC collection, patients receive high-dose chemotherapy comprising carmustine IV on days -7 to -3
  • cisplatin — DRUG
    After completion of PBSC collection, cisplatin IV for 3 days during days -7 to -3.
  • cyclophosphamide — DRUG
    cyclophosphamide IV over 3-6 hours on day 16.
  • etoposide — DRUG
    After completion of PBSC collection, etoposide IV for 3 days during days -7 to -3.
  • bone marrow ablation with stem cell support — PROCEDURE
    Patients then undergo peripheral blood stem cell (PBSC) collection.
  • peripheral blood stem cell transplantation — PROCEDURE
    Arm I: Patients receive unmanipulated PBSCs on day 0. Arm II: Patients receive CD34 cell-enriched PBSC on day 0.
  • radiation therapy — RADIATION
    Patients may undergo involved-field radiotherapy to active or previously bulky (more than 5 cm) tumors daily for 7-10 days.

Study Details

RATIONALE: Monoclonal antibodies such as rituximab can locate cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells. It is not yet known if combining rituximab with cyclophosphamide is more effective than cyclophosphamide alone in stimulating peripheral stem cells for transplantation. PURPOSE: This randomized phase II trial is studying how well giving cyclophosphamide with or without rituximab followed by chemotherapy and peripheral stem cell transplantation works in treating patients with recurrent non-Hodgkin's lymphoma.

Key Dates

Start date
Jun 30, 2000
Status verified
Jun 2010
Primary completion
Mar 31, 2005

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I: with rituximab IV
  • Active Comparator: Arm II: without rituximab IV

Primary Outcome Measure

Total CD34 cells [ Time Frame: measured at baseline, at time of harvests, days 42 and 90 after the transplant, and 6 and 12 months after the transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve UniversityClevelandOhio44106-7284-

Find similar trials in Cleveland, OH

By research site
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University· Cleveland, OH

Related Studies