Chemotherapy, Radiation Therapy, Rituximab, and Umbilical Cord Blood Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma

Part of paid clinical trials in New York, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00387959
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • filgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • cyclosporine — DRUG
  • fludarabine phosphate — DRUG
  • mycophenolate mofetil — DRUG
  • allogeneic hematopoietic stem cell transplantation — PROCEDURE
  • umbilical cord blood transplantation — PROCEDURE
  • total-body irradiation — RADIATION

Study Details

RATIONALE: Giving low doses of chemotherapy, such as cyclophosphamide and fludarabine, total-body irradiation, and rituximab before a donor umbilical cord blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune cells and help destroy any remaining cancer cells (graft-versus-tumor effect). Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. PURPOSE: This phase II trial is studying how well giving chemotherapy and radiation therapy together with rituximab and an umbilical cord blood transplant works in treating patients with B-cell non-Hodgkin's lymphoma.

Key Dates

Start date
Jul 31, 2006
Status verified
Dec 2015
Primary completion
Apr 30, 2014
Completion
Apr 30, 2014

Study Design

Enrollment
17 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Unrelated Donor Umbilical Cord Transplant
    Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood

Primary Outcome Measure

Survival at 1 Year After Transplantation [ Time Frame: 1 Year after transplant ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10065-

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