NCT03970096View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

November 19, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2028

Conditions
Acute LeukemiaAcute Lymphoblastic LeukemiaAcute Myeloid LeukemiaMyelodysplastic SyndromeMyeloproliferative Neoplasm
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

Trial Locations (3)

15232

RECRUITING

University of Pittsburgh Cancer Institute (UPCI), Pittsburgh

33612

RECRUITING

Moffitt Cancer Center, Tampa

98109

RECRUITING

Fred Hutch/University of Washington Cancer Consortium, Seattle

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Fred Hutchinson Cancer Center

OTHER