Clinical Trials

IRB Study Number 18-379

Status Recruiting

Location Cleveland Clinic Main Campus

Institute Taussig Cancer Institute

Description

HLA-Matched Donor HCT Study

• Primary objectives

  • Compare the five-year survival probabilities from DIPSS assessment between the two study arms. Two co-primary analyses will be conducted, one for all alloHCT patients versus Arm 2 and one for the subset of patients receiving MAC prior to alloHCT patients versus Arm 2.

  • Arm 1: AlloHCT recipients

  • Arm 2: Non-HCT therapies (ruxolitinib / best supportive care recipients)

• Secondary objectives

  • Compare LFS at five years from DIPSS assessment. Two co-secondary analyses will be conducted, one for all alloHCT patients versus Arm 2 and one for the subset of patients receiving MAC prior to alloHCT versus Arm 2.
  • Identify patient-, disease-, and HCT-related factors associated with poor HCT outcomes in the alloHCT arm.
  • Estimate the cumulative incidences of acute (II-IV and III-IV) and (limited and extensive) chronic GVHD, starting at HCT in the alloHCT arm.
  • Estimate the cumulative incidence of TRM and relapse starting at HCT in the alloHCT arm.
    Haploidentical Donor Study

• Primary objectives

  • Estimate the five-year survival probabilities with haploidentical HCT from DIPSS assessment (collected prior to JAK2 inhibitor therapy initiation).

• Secondary objectives

  • Estimate five-year LFS with haploidentical HCT from DIPSS assessment (collected prior to JAK2 inhibitor therapy initiation).
  • Identify patient-, disease-, and HCT-related factors associated with poor outcomes post haploidentical HCT, starting at HCT.
  • Estimate the cumulative incidences of acute (II-IV and III-IV) and (limited and extensive) chronic GVHD, starting at HCT.
  • Estimate the five-year cumulative incidences of relapse and TRM, starting at HCT.

Inclusion Criteria

1. PMF, post-ET MF, or post-PV MF.
2. Int-2 or high-risk disease as determined by the DIPSS.
3. Age ≥55 at the time of DIPSS assessment.

4. 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.
5. Haploidentical donors are allowed in the Haploidentical Donor Study (Section 3.0).

Exclusion Criteria

1. 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).
2. Overlap syndromes.