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Laboratory-Treated Lymphocyte Infusion After Haploidentical Donor Stem Cell Transplant

NCT00376480 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2019-07-05

No results posted yet for this study

Summary

RATIONALE: Giving total-body irradiation and chemotherapy, such as thiotepa and fludarabine, before a donor stem cell transplant helps stop the growth of cancer or abnormal cells. It also helps 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 methylprednisolone and antithymocyte globulin before transplant and peripheral blood cells that have been treated in the laboratory after transplant may stop this from happening.

PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated peripheral blood cell infusion after donor stem cell transplant in treating patients with hematologic cancers or other diseases.

Conditions

Interventions

BIOLOGICAL

anti-thymocyte globulin

BIOLOGICAL

peripheral blood lymphocyte therapy

DRUG

fludarabine phosphate

DRUG

methylprednisolone

DRUG

thiotepa

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

  • Dana-Farber Cancer Institute

    lead OTHER

Principal Investigators

  • Eva Guinan, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2010-06-30
Completion
2018-05-16

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT00376480 on ClinicalTrials.gov