Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary Myelofibrosis

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorFred Hutchinson Cancer Center

About this trial

This initial cohort of this phase II trial studied the outcomes of using a JAK inhibitor prior to reduced intensity haploidentical (Haplo) transplantation for the treatment of primary or secondary myelofibrosis (MF). The primary risk of using Haplo HCT in patients with MF is graft failure. In the first cohort, all patients engrafted. There were no instances of graft failure. However, a large number of patients did have graft versus host disease as a complication of their transplant. JAK inhibitors have since been approved for the indication of graft versus host disease treatment. And we are also using them for graft versus host disease prevention in a study of MF patients with sibling and unrelated donors. Therefore, we are opening a new cohort of the current study using the JAK inhibitor prior to, during and after Haplo transplant. Our goal is to decrease graft versus host disease in patients receiving a Haplo MF transplant without increasing the risk of graft failure.

Eligibility criteria

Qualifiers

PART 1: JAK INHIBITOR ADMINISTRATION INCLUSION CRITERIA

Age between 18 and 70 years

Diagnosis of primary myelofibrosis (PMF) as defined by the 2016 World Health Organization classification system or diagnosis of secondary MF as defined by the International Working Group (IWG) for Myeloproliferative Neoplasms Research and Treatment criteria

Patients meeting the criteria for intermediate-1, intermediate-2 or high-risk disease by the Dynamic International Prognostic Scoring System (DIPSS)-plus scoring system (DIPSS may be used if all data from DIPSS are not available)

Disqualifiers

PART 1: JAK INHIBITOR ADMINISTRATION EXCLUSION CRITERIA

Patients who have known hypersensitivity to JAK inhibitors

Clinical or laboratory evidence of significant renal or hepatic impairment including cirrhosis

Active uncontrolled infection

Trial design

Treatments tested in this trial

  • Cyclophosphamide
  • JAK Inhibitor
  • Fludarabine
  • Recombinant Granulocyte Colony-Stimulating Factor
  • Melphalan
  • Mycophenolate Mofetil
  • Peripheral Blood Stem Cell Transplantation
  • Tacrolimus
  • Total-Body Irradiation
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Bone Marrow Biopsy
  • Bone Marrow Aspiration
  • Biospecimen Collection
  • Echocardiography Test
  • Multigated Acquisition Scan

Treatment groups

20 Participants
are divided into 2 treatment groups

Sponsors and collaborators