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RECRUITING
NCT03970096
PHASE2

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

Sponsor: Fred Hutchinson Cancer Center

View on ClinicalTrials.gov

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.

Official title: A Phase II Randomized Controlled Trial Comparing GVHD-Reduction Strategies for Allogeneic Peripheral Blood Transplantation (PBSCT) for Patients With Acute Leukemia or Myelodysplastic Syndrome: Selective Depletion of CD45RA+ Naïve T Cells (TND) vs. Post-Transplantation Cyclophosphamide (PTCy)

Key Details

Gender

All

Age Range

1 Year - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2019-11-19

Completion Date

2029-12-31

Last Updated

2026-03-12

Healthy Volunteers

No

Interventions

RADIATION

Total-Body Irradiation

Undergo TBI

DRUG

Thiotepa

Given IV

DRUG

Fludarabine

Given IV

DRUG

Tacrolimus

Given IV

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

Locations (3)

Moffitt Cancer Center

Tampa, Florida, United States

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States