Chemotherapy, Total-Body Irradiation, Rituximab, and Donor Stem Cell Transplant in Treating Patients With B-Cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia

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

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT00425802
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • anti-thymocyte globulin — BIOLOGICAL
  • filgrastim — BIOLOGICAL
  • graft-versus-tumor induction therapy — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • cyclophosphamide — DRUG
  • cyclosporine — DRUG
  • fludarabine phosphate — DRUG
  • mycophenolate mofetil — DRUG
  • nonmyeloablative allogeneic hematopoietic stem cell transplantation — PROCEDURE
  • total-body irradiation — RADIATION

Study Details

RATIONALE: Giving low doses of chemotherapy and total-body irradiation before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. Also, monoclonal antibodies, such as rituximab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal 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 rituximab before transplant and cyclosporine and mycophenolate mofetil after transplant may stop this from happening. PURPOSE: This phase II trial is studying the side effects and how well giving chemotherapy and radiation therapy together with rituximab and donor stem cell transplant works in treating patients with B-cell non-Hodgkin's lymphoma or chronic lymphocytic leukemia.

Key Dates

Start date
Nov 28, 2006
Status verified
Feb 2017
Primary completion
Oct 28, 2016
Completion
Oct 28, 2016

Study Design

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

Arms

  • Other: treatment
    This is a phase 2 study of a treatment regimen consisting of a non-myeloablative (NMA) conditioning regimen incorporating low dose chemotherapy and low dose radiation as well as peri-transplant Rituximab and the transplantation of peripheral blood stem cells (PBSC) or bone marrow if PBSC collection not possible from an HLA compatible related or unrelated donor in patients with B cell lymphoid malignancies including diffuse large cell (DLC) and mantle cell non-Hodgkin's lymphoma (NHL), indolent B cell NHL, or chronic lymphocytic leukemia (CLL).

Primary Outcome Measure

Overall Survival at 1 Year [ Time Frame: 1 year ]

Locations (1)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-

Find similar trials in New York, NY

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering Cancer Center· New York, NY

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