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Observational Study of Stem Cell Transplant for Myelofibrosis

This observational study is looking at how well a Hematopoietic Stem Cell Transplant (HCT), also known as a bone marrow transplant, works for people with myelofibrosis. Researchers are comparing the health outcomes of people who receive an HCT to those who don't. You may be able to join if you have primary myelofibrosis (PMF), myelofibrosis after essential thrombocythemia (post-ET MF), or myelofibrosis after polycythemia vera (post-PV MF), and are at least 55 years old with intermediate-2 or high-risk disease. The main goal is to see how many people are still alive five years after their transplant. The study status is currently unclear.

Study design
This is an observational study comparing outcomes in about 650 people who receive a stem cell transplant to a group of people who did not. It is not a randomized trial.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for five years after their transplant to assess survival.

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NCT02934477

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Recruiting
Not specifiedAges 55+Observational
Center for International Blood and Marrow Transplant Research
~650 participants
Updated 2023-08-30 on ClinicalTrials.gov
What's tested:Hematopoietic Stem Cell Transplant

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Compare five year survival
Measured over Five years post transplant

Conditions

Myelofibrosis

Explore related trials

MyelofibrosisHLA Complex

Where it's being run

1 sites across 1 states
Minnesota1

Study leadership

  • Wael Saber, MD · STUDY_CHAIR · Medical College of Wisconsin
  • Laura Michaelis, MD · STUDY_CHAIR · Medical College of Wisconsin

Who to contact

Patricia Steinert, PhD
[email protected]
414-805-0700
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Compare five year survivalFive years post transplant

    Compare the five-year survival probabilities from DIPSS assessment between the two study arms: alloHCT recipients (arm 1) and non-HCT therapies (ruxolitinib / best supportive care) recipients (arm 2).