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A Two-Step Approach to Bone Marrow Transplant Using Cells From A Partially-Matched Relative

NCT00429143 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2025-05-04

Study results available
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Summary

The purpose of this study is to develop a way of treating patients who do not have a completely matched family donor or a readily available unrelated donor with bone marrow transplant by using a partially-matched family donor. Patients receiving this type of transplant will receive chemotherapy and/or radiation to treat their disease. They will also receive their donor's cells in 2 parts. During the first part, the donor's lymphocytes will be exposed to one of the chemotherapy agents to help the patient become tolerant to the lymphocytes. In the second part of the transplant, the patient will receive their donor's stem cells to help recover their peripheral blood counts and establish long-term engraftment. The hypothesis of this study is that in partially-matched allogeneic transplant, there is a defined number of donor T-cells that can be treated and given to the recipient to avoid post-transplant infection without causing severe graft-versus-host disease.

Conditions

Interventions

RADIATION

Total Body Irradiation (TBI)

TBI twice daily days 6-9 prior to transplant (HSCT)

BIOLOGICAL

Donor Lymphocyte Infusion (DLI)

DLI given 6 days prior to transplant (HSCT).

DRUG

Cyclophosphamide (CY)

Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).

DRUG

Tacrolimus

Tacrolimus given one day prior to transplant (HSCT).

DRUG

Mycophenolate Mofetil (MMF)

MMF given one day prior to transplant (HSCT).

BIOLOGICAL

Hematopoietic Stem Cell Transplant (HSCT)

CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed. This is the day of transplantation.

Sponsors & Collaborators

  • Sidney Kimmel Cancer Center at Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Neal Flomenberg, MD · Thomas Jefferson University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2009-08-31
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT00429143 on ClinicalTrials.gov