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Recruiting NCT02934477

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Trial Parameters

Condition Myelofibrosis
Sponsor Center for International Blood and Marrow Transplant Research
Study Type OBSERVATIONAL
Phase N/A
Enrollment 650
Sex ALL
Min Age 55 Years
Max Age N/A
Start Date 2016-11
Completion 2026-11
Interventions
Hematopoietic Stem Cell Transplant

Brief 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.

Eligibility Criteria

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

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