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Graft Versus Host Disease-Reduction Strategies for Donor Blood Stem Cell Transplant Patients With Acute Leukemia or Myelodysplastic Syndrome (MDS)

NCT03970096 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-12

No results posted yet for this study

Summary

This phase II trial investigates two strategies and how well they work for the reduction of graft versus host disease in patients with acute leukemia or MDS in remission. Giving chemotherapy and total-body irradiation before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and 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. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Conditions

Interventions

BIOLOGICAL

Allogeneic CD34+-enriched and CD45RA-depleted PBSCs

Given IV

DRUG

Methotrexate

Given IV

DRUG

Cyclophosphamide

Given IV

BIOLOGICAL

Peripheral Blood Stem Cell

Given IV

DRUG

Cyclosporine

Given IV

DRUG

Sirolimus

Given IV

DRUG

Busulfan

Given IV

PROCEDURE

Bone Marrow Aspiration and Biopsy

Undergo bone marrow aspiration/biopsy

PROCEDURE

Echocardiography

Undergo ECHO

PROCEDURE

Multigated Acquisition Scan

Undergo MUGA

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Thiotepa

Given IV

DRUG

Fludarabine

Given IV

DRUG

Tacrolimus

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Fred Hutchinson Cancer Center

    lead OTHER

Principal Investigators

  • Marie Bleakley · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03970096 on ClinicalTrials.gov