Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

  • STATUS
    Recruiting
  • End date
    Oct 6, 2027
  • participants needed
    650
  • sponsor
    Center for International Blood and Marrow Transplant Research
Updated on 6 April 2022
stem cell transplantation
graft versus host disease
hla-a
polycythemia

Summary

This observational study will compare outcomes of a prospectively-enrolled cohort of Hematopoietic Stem Cell Transplant (HCT) recipients with outcomes of a cohort of age-matched historical non-HCT controls. Patients undergoing alloHCT will receive HCT in a US transplant center and be reported to the Center for International Blood and Marrow Transplant Research (CIBMTR) using well-established CIBMTR report forms and data collection procedures as well as a study-specific supplemental form. Data on the historical non-HCT controls will be collected at 14 US academic centers. These centers will provide data on all consecutive patients with PMF, post-ET MF, or post-PV MF referred to their institutions between 2000 and 2012.

Description

Patients with primary MF (PMF), post-essential thrombocythemia (ET) MF, or post-polycythemia vera (PV) MF, with intermediate-2 or high-risk disease as determined by the DIPSS, and aged ≥55 at the time of DIPSS assessment are eligible for this study. For the allogeneic HCT arm of the HLA-Matched Donor HCT Study, donors must be either 6/6 HLA-matched related donors, defined by Class I (HLA-A and -B) intermediate resolution or high resolution DNA-based typing and Class II (HLA-DRBI) at high resolution DNA-based typing (but not monozygotic twins), OR an 8/8 HLA-A, -B, -C, and -DRB1 at high resolution DNA-based typing matched unrelated donors; both peripheral blood stem cells and bone marrow grafts are allowed, and all conditioning regimen intensities and graph versus host disease (GVHD) prophylaxis regimens are allowed. For the Haploidentical Donor Study, donors must be haploidentical.

This study will target accrual of 650 patients receiving alloHCT, including approximately 225 receiving myeloablative conditioning. Participating centers are expected to provide data for approximately 2,400 patients to form the non-HCT historical control cohort.

Details
Condition Myelofibrosis
Treatment Hematopoietic Stem Cell Transplant
Clinical Study IdentifierNCT02934477
SponsorCenter for International Blood and Marrow Transplant Research
Last Modified on6 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients fulfilling the following criteria will be eligible for inclusion in the
study
PMF, post-ET MF, or post-PV MF
Int-2 or high-risk disease as determined by the DIPSS
Age ≥55 at the time of DIPSS assessment
For the alloHCT arm
Donors must be a 6/6 HLA-matched related donors, defined by Class I (HLA-A and -B) intermediate resolution or high resolution DNA-based typing and Class II (HLA-DRBI) at high resolution DNA-based typing (but not monozygotic twins) OR an 8/8 HLA-A, -B, -C, and -DRB1 at high resolution DNA-based typing matched unrelated donor identified through the National Marrow Donor Program (NMDP)/Be The Match. Donors must meet institutional or NMDP/Be The Match selection criteria; there is no age restriction for sibling donors
Both peripheral blood stem cells and bone marrow grafts are allowed
All conditioning regimen intensities are allowed
All GVHD prophylaxis regimens are allowed
Haploidentical donors are allowed in the Haploidentical Donor Study

Exclusion Criteria

Patients with the following criteria will be ineligible for entry into the study
AlloHCT using umbilical cord blood unit(s) or HLA-mismatched adult donors (< 6/6 HLA alleles for related and < 8/8 HLA alleles for unrelated)
Overlap syndromes
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