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Donor Stem Cell Transplant in Treating Older or Frail Patients With Hematologic Cancer

NCT00296023 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-10-04

No results posted yet for this study

Summary

RATIONALE: Giving low doses of chemotherapy, such as fludarabine and busulfan, before a donor bone marrow or peripheral 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 system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving antithymocyte globulin before transplant and methotrexate and tacrolimus after the transplant may stop this from happening.

PURPOSE: This phase I trial is studying the side effects of donor stem cell transplant in treating older or frail patients with hematologic cancer.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

filgrastim

BIOLOGICAL

therapeutic allogeneic lymphocytes

DRUG

busulfan

DRUG

fludarabine phosphate

DRUG

methotrexate

DRUG

tacrolimus

PROCEDURE

nonmyeloablative allogeneic hematopoietic stem cell transplantation

PROCEDURE

peripheral blood stem cell transplantation

Sponsors & Collaborators

Principal Investigators

  • Thomas G. Martin, MD · University of California, San Francisco

  • Willis Navarro, MD · University of California, San Francisco

  • Charles A. Linker, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2007-06-30
Completion
2008-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

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 NCT00296023 on ClinicalTrials.gov