Assessing Hematopoietic Cell Transplantation for Myelofibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to compare outcomes between patients with myelofibrosis who undergo allogeneic hematopoietic cell transplantation (HCT) and a cohort of historical non-HCT controls. Eligible patients include those with primary myelofibrosis, post-essential thrombocythemia myelofibrosis, or post-polycythemia vera myelofibrosis, aged 55 or older with intermediate-2 or high-risk disease. Data will be collected from multiple US academic centers, focusing on both HCT recipients and historical controls to evaluate the effectiveness of the treatment. The study will enroll approximately 650 patients receiving HCT and collect data from around 2,400 historical controls.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Study coordinator: Patricia Steinert, PhD
• Email: psteinert@mcw.edu
• Phone: 414-805-0700

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating DISC-0974 for treating anemia in myelofibrosis patients

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• TQ05105 tablets for intermediate/high-risk myelofibrosis

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.