Clinical trialNCT03970096RecruitingPhase 2Interventional

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

SponsorFred Hutchinson Cancer CenterEnrollment120Acute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic SyndromeMyeloproliferative Neoplasm

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Marie Bleakley
Fred Hutch/University of Washington Cancer Consortium
Principal Investigator
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A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Moffitt Cancer Center
Tampa, Florida, United States
Taiga Nishihori
Recruiting
University of Pittsburgh Cancer Institute (upci)
Pittsburgh, Pennsylvania, United States
Alison Sehgal
Recruiting
Fred Hutch/university of Washington Cancer Consortium
Seattle, Washington, United States
Marie Bleakley
Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Allogeneic CD34+-enriched and CD45RA-depleted PBSCsBusulfan →Cyclophosphamide →Cyclosporine →Fludarabine →Methotrexate →Peripheral Blood Stem CellSirolimus →Tacrolimus →Thiotepa

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 19 Nov 2019
Primary completion: 31 Dec 2027
Completion: 31 Dec 2029
Last update posted: 12 Mar 2026
Registered enrollment: 120
Registry id: NCT03970096

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.