Prospective Assessment of Allogeneic Hematopoietic Cell Transplantation in Patients With Myelofibrosis
| Status: | Recruiting |
|---|---|
| Conditions: | Hematology |
| Therapuetic Areas: | Hematology |
| Healthy: | No |
| Age Range: | 55 - Any |
| Updated: | 7/29/2017 |
| Start Date: | November 2016 |
| End Date: | October 2027 |
| Contact: | Patricia Steinert, PhD |
| Email: | psteinert@mcw.edu |
| Phone: | 414-805-0700 |
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.
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.
Patients with primary MF (PMF), post-essential thrombocythemia (ET) MF, or post-polycythemia
vera (PV) MF, with intermediate-2 or high-risk disease as determined by the DIPSS, and aged
≥55 at the time of DIPSS assessment are eligible for this study. For the allogeneic HCT arm
of the HLA-Matched Donor HCT Study, donors must be either 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 donors;
both peripheral blood stem cells and bone marrow grafts are allowed, and all conditioning
regimen intensities and graph versus host disease (GVHD) prophylaxis regimens are allowed.
For the Haploidentical Donor Study, donors must be haploidentical.
This study will target accrual of 650 patients receiving alloHCT, including approximately 225
receiving myeloablative conditioning. Participating centers are expected to provide data for
approximately 2,400 patients to form the non-HCT historical control cohort.
vera (PV) MF, with intermediate-2 or high-risk disease as determined by the DIPSS, and aged
≥55 at the time of DIPSS assessment are eligible for this study. For the allogeneic HCT arm
of the HLA-Matched Donor HCT Study, donors must be either 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 donors;
both peripheral blood stem cells and bone marrow grafts are allowed, and all conditioning
regimen intensities and graph versus host disease (GVHD) prophylaxis regimens are allowed.
For the Haploidentical Donor Study, donors must be haploidentical.
This study will target accrual of 650 patients receiving alloHCT, including approximately 225
receiving myeloablative conditioning. Participating centers are expected to provide data for
approximately 2,400 patients to form the non-HCT historical control cohort.
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.
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