NCT02934477Recruiting
Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis
Source: ClinicalTrials.gov · Last updated 30 Aug 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 650 (estimated)
- First submitted
- 30 Sept 2016
- Start date
- Nov 2016
- Primary completion date
- Nov 2026
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Diseases
- Myeloproliferative neoplasms
- NCT number
- NCT02934477
What you commit to
- Study type: Observational
- Planned participants: 650
- From Nov 2016 to the primary completion date, Nov 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center for International Blood and Marrow Transplant Research Coordinator of this site? Confirm its status | Minneapolis | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.