RECRUITING

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis

Quick Facts

Study Start:2016-11
Study Completion:2027-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT02934477

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients fulfilling the following criteria will be eligible for inclusion in the study:
  2. * PMF, post-ET MF, or post-PV MF.
  3. * Int-2 or high-risk disease as determined by the DIPSS.
  4. * Age ≥55 at the time of DIPSS assessment.
  5. * For the alloHCT arm:
  6. * 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.
  7. * Both peripheral blood stem cells and bone marrow grafts are allowed.
  8. * All conditioning regimen intensities are allowed.
  9. * All GVHD prophylaxis regimens are allowed.
  10. * Haploidentical donors are allowed in the Haploidentical Donor Study
  1. * Patients with the following criteria will be ineligible for entry into the study:
  2. * 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).
  3. * Overlap syndromes.

Contacts and Locations

Study Contact

Patricia Steinert, PhD
CONTACT
414-805-0700
psteinert@mcw.edu
Stephanie Farnia
CONTACT
763-406-8640
sfarnia@nmdp.org

Principal Investigator

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

Study Locations (Sites)

Center for International Blood and Marrow Transplant Research
Minneapolis, Minnesota, 55401
United States

Collaborators and Investigators

Sponsor: Center for International Blood and Marrow Transplant Research

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-11
Study Completion Date2027-10

Study Record Updates

Study Start Date2016-11
Study Completion Date2027-10

Terms related to this study

Keywords Provided by Researchers

  • Myelofibrosis
  • Hematopoietic Stem Cell Transplant
  • Medicare

Additional Relevant MeSH Terms

  • Myelofibrosis