Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 55
Healthy Volunteers: f
View:

• 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

Locations
United States
Minnesota
Center for International Blood and Marrow Transplant Research
RECRUITING
Minneapolis
Contact Information
Primary
Patricia Steinert, PhD
psteinert@mcw.edu
414-805-0700
Backup
Stephanie Farnia
sfarnia@nmdp.org
763-406-8640
Time Frame
Start Date: 2016-11
Estimated Completion Date: 2027-10
Participants
Target number of participants: 650
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: National Marrow Donor Program, National Institutes of Health (NIH), National Cancer Institute (NCI)
Leads: Center for International Blood and Marrow Transplant Research

This content was sourced from clinicaltrials.gov

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