Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Description

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.

Conditions

Myelofibrosis

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Study Overview

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Study Details

Study overview

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.

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Condition
Myelofibrosis
Intervention / Treatment

-

Contacts and Locations

Minneapolis

Center for International Blood and Marrow Transplant Research, Minneapolis, Minnesota, United States, 55401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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.

Ages Eligible for Study

55 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Center for International Blood and Marrow Transplant Research,

Wael Saber, MD, STUDY_CHAIR, Medical College of Wisconsin

Laura Michaelis, MD, STUDY_CHAIR, Medical College of Wisconsin

Study Record Dates

2027-10