Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

ConditionMyelofibrosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorCenter for International Blood and Marrow Transplant Research

About this trial

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.

Eligibility criteria

Qualifiers

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.

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Hematopoietic Stem Cell Transplant

Treatment groups

650 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Center for International Blood and Marrow Transplant Research

Lead sponsor

National Marrow Donor Program

Collaborator

National Institutes of Health (NIH)

Collaborator

National Cancer Institute (NCI)

Collaborator