Recruiting

Allogeneic Transplantation

Sponsor:

Center for International Blood and Marrow Transplant Research

Code:

NCT02934477

Conditions

Myelofibrosis

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

Interventions

Hematopoietic Stem Cell Transplant

Study Details

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.

Conditions

Myelofibrosis

Study ID

NCT02934477

Start date

Nov, 2016

Status verified date

Aug, 2023

Completion date

Oct, 2027

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 55+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

Hematopoietic Stem Cell Transplant (HCT)

Patients undergoing alloHCT in a US transplant center and reported to the CIBMTR

Non-HCT

Historical non-transplant controls collected from 14 US academic centers. 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.

Interventions

Hematopoietic Stem Cell Transplant

This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of age-matched non-HCT controls.

Primary outcome measure

  • Compare five year survival [ Time Frame: Five years post transplant ]

Central Contacts and Locations

Central contacts

Patricia Steinert, PhD

414-805-0700psteinert@mcw.edu

Stephanie Farnia

763-406-8640sfarnia@nmdp.org

Locations

Center for International Blood and Marrow Transplant Research

Recruiting

Minneapolis, Minnesota, United States, 55401

Contacts

Michael Tierney

DatabaseIRB@NMDP.org

More Information

Sponsor

Center for International Blood and Marrow Transplant Research

Last update posted

Aug 30, 2023

Last verified

Aug, 2023

Keywords

  • Myelofibrosis
  • Hematopoietic Stem Cell Transplant
  • Medicare

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Center for International Blood and Marrow Transplant Research on 2023-08-30.