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Fludarabine Phosphate, Low-Dose Total-Body Irradiation, and Peripheral Blood Stem Cell Transplant Followed by Donor Lymphocyte Infusion in Treating Older Patients With Chronic Myeloid Leukemia

NCT00003145 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2020-01-10

No results posted yet for this study

Summary

This clinical trial studies fludarabine phosphate, low-dose total-body irradiation, and peripheral blood stem cell transplant followed by donor lymphocyte infusion in treating older patients with chronic myeloid leukemia. Giving chemotherapy and total-body irradiation before a donor bone marrow transplant helps stop the growth of cancer cells. It may also stop the patient's immune system from rejecting the donor's stem 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 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.

Conditions

  • Accelerated Phase of Disease
  • Childhood Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Myelogenous Leukemia, BCR-ABL1 Positive
  • Chronic Phase of Disease
  • Recurrent Disease

Interventions

DRUG

Fludarabine Phosphate

Given IV

RADIATION

Total-Body Irradiation

Undergo TBI

PROCEDURE

Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation

Undergo allogeneic PBSCT

PROCEDURE

Peripheral Blood Stem Cell Transplantation

Undergo allogeneic PBSCT

DRUG

Cyclosporine

Given PO or IV

DRUG

Mycophenolate Mofetil

Given PO or IV

BIOLOGICAL

Therapeutic Allogeneic Lymphocytes

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Brenda Sandmaier · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
74 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1997-08-31
Primary Completion
2005-03-31

Countries

  • United States
  • Germany
  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00003145 on ClinicalTrials.gov