Actively Recruiting

Phase 2
Age: 1Year - 60Years
All Genders
NCT03970096

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

Led by Fred Hutchinson Cancer Center · Updated on 2026-03-12

120

Participants Needed

3

Research Sites

527 weeks

Total Duration

On this page

Sponsors

F

Fred Hutchinson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 1Year - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients appropriate for myeloablative, TBI-containing allogeneic stem cell transplant with diagnosis of acute lymphocytic leukemia, acute myeloid leukemia, other acute leukemia or related neoplasm, or myelodysplastic syndrome with history of excess marrow blasts and recent cytoreductive therapy
  • Patients aged 1 to 60 years inclusive at time of consent
  • Patients aged 1 to 50 years eligible for TBI-based conditioning
  • Patients aged 1 to 60 years eligible for busulfan-based conditioning with or without low-dose TBI
  • Patient has HLA-matched related or unrelated donor capable of donating peripheral blood stem cells
  • Recipient informed consent or legal guardian permission obtained
  • Donor aged 18 years or older, willing to donate peripheral blood stem cells
  • Donors must meet institutional or National Marrow Donor Program eligibility and consent requirements
Not Eligible

You will not qualify if you...

  • Patients with refractory central nervous system involvement not cleared before conditioning
  • Patients on other experimental GVHD prevention protocols
  • Patients weighing 110 kg or more with matched related donors; patients weighing 110 kg or more with matched unrelated donors excluded; weight 90 kg or more with matched unrelated donors requires discussion
  • Patients positive for HIV-1, HIV-2, HTLV-1, or HTLV-2
  • Patients with uncontrolled infections contraindicating transplant
  • Patients with organ dysfunction including renal insufficiency (creatinine > 1.5 mg/dl), left ventricular ejection fraction < 45%, lung capacity (DLCO) < 60%, or abnormal liver function tests unless cleared
  • Patients with previous myeloablative allogeneic or autologous transplantation
  • Patients with life expectancy under 12 months from other diseases
  • Pregnant or breastfeeding patients
  • Patients of childbearing potential unwilling to use effective birth control during and 12 months after transplant
  • Patients with significant medical conditions making transplantation unsafe
  • Patients with known hypersensitivity to tacrolimus or methotrexate
  • Patients who received checkpoint inhibitors within 3 months of transplant unless approved
  • Donors positive for HIV, HTLV, or active hepatitis B or C infection
  • Unrelated donors donating outside the USA

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Moffitt Cancer Center

Tampa, Florida, United States, 33612

Actively Recruiting

2

University of Pittsburgh Cancer Institute (UPCI)

Pittsburgh, Pennsylvania, United States, 15232

Actively Recruiting

3

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States, 98109

Actively Recruiting

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Research Team

M

Marie Bleakley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

6

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