Fludarabine and Cyclophosphamide in Treating Patients Who Are Undergoing Donor Stem Cell Transplant for Chronic Lymphocytic Leukemia or Waldenstrom's Macroglobulinemia

Sponsor
German CLL Study Group
Study ID
NCT00281983
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • alemtuzumab — BIOLOGICAL
  • anti-thymocyte globulin — BIOLOGICAL
  • filgrastim — BIOLOGICAL
  • rituximab — BIOLOGICAL
  • therapeutic allogeneic lymphocytes — BIOLOGICAL
  • busulfan — DRUG
  • cyclophosphamide — DRUG
  • cyclosporine — DRUG
  • fludarabine phosphate — DRUG
  • methotrexate — DRUG
  • mycophenolate mofetil — DRUG
  • peripheral blood stem cell transplantation — PROCEDURE
  • radiation therapy — RADIATION

Study Details

RATIONALE: Giving chemotherapy before a donor bone marrow 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 alemtuzumab, can find cancer cells and either kill them or deliver cancer-killing substances to them without harming normal cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving methotrexate, cyclosporine and mycophenolate mofetil after the transplant may stop this from happening. Once the donated stem cells begin working, the patient's immune system may see the remaining cancer cells as not belonging in the patient's body and destroy them (called graft-versus-tumor effect). Giving an infusion of the donor's white blood cells (donor lymphocyte infusion) may boost this effect. PURPOSE: This phase I/II trial is studying the side effects of giving fludarabine together with cyclophosphamide and to see how well they work in treating patients who are undergoing donor stem cell transplant for B-cell chronic lymphocytic leukemia or Waldenström's macroglobulinemia.

Key Dates

Start date
Jun 30, 2000
Status verified
Apr 2007
Completion
Jul 31, 2010

Study Design

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

Arms

  • Experimental: Allogeneic stem cell transplantation
    1. Cytoreductive therapy for inducing a state of partial remission: FC or FC-R or alternative salvage regimens (e.g. Alemtuzumab) 2. Conditioning regimen: FC +/- ATG (Arm A) or FC/Busulfan +/- ATG (Arm C: refractory patients only) 3. allogeneic-PBSCT (from HLA-identical donor) 4. GVHD prophylaxis: CSA + MTX or MMF 5. +/- DLI (Donor lymphocyte infusions)

Primary Outcome Measure

Feasibility as measured by the proportion of eligible patients completing the transplant procedure successfully

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