NCT02934477 Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis
| NCT ID | NCT02934477 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Center for International Blood and Marrow Transplant Research |
| Condition | Myelofibrosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2016-11 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2016-11 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Wael Saber, MD
STUDY CHAIR
Medical College of Wisconsin
Frequently Asked Questions
Who can join the NCT02934477 clinical trial?
This trial is open to participants of all sexes, aged 55 Years or older, studying Myelofibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02934477 currently recruiting?
Yes, NCT02934477 is actively recruiting participants. Contact the research team at psteinert@mcw.edu for enrollment information.
Where is the NCT02934477 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT02934477 clinical trial?
NCT02934477 is sponsored by Center for International Blood and Marrow Transplant Research. The principal investigator is Wael Saber, MD at Medical College of Wisconsin. The trial plans to enroll 650 participants.