Donor Peripheral Stem Cell Transplant and Donor Natural Killer Cell Transplant After Total-Body Irradiation, Thiotepa, Fludarabine, and Muromonab-CD3 in Treating Patients With Leukemia or Other Blood Diseases

NCT00450983 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2017-05-24

Study results available
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Summary

RATIONALE: Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell and donor natural killer cell transplant helps stop the growth of cancer and abnormal cells and helps stop the patient's immune system from rejecting the donor's stem cells. When certain 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. Removing the T cells from the donor cells before transplant may stop this from happening.

PURPOSE: This phase II trial is studying how well giving a donor peripheral stem cell transplant and a donor natural killer cell transplant after total-body irradiation, thiotepa, fludarabine, and muromonab-CD3 works in treating patients with leukemia or other blood diseases.

Conditions

Interventions

BIOLOGICAL

muromonab-CD3

BIOLOGICAL

natural killer cell therapy

DRUG

fludarabine phosphate

DRUG

methotrexate

DRUG

thiotepa

GENETIC

gene expression analysis

OTHER

flow cytometry

OTHER

immunologic technique

PROCEDURE

allogeneic hematopoietic stem cell transplantation

PROCEDURE

in vitro-treated peripheral blood stem cell transplantation

RADIATION

total-body irradiation

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH
  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH
  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Ann Woolfrey, MD · Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Study Design

Purpose
TREATMENT
Masking
NONE

Eligibility

Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-12-31
Primary Completion
2010-07-31
Completion
2010-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00450983 on ClinicalTrials.gov