Reduced Intensity Haploidentical Transplantation for the Treatment of Primary or Secondary
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 pati
| Condition(s) | Primary Myelofibrosis, Secondary Myelofibrosis |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| Summary | 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 |
| Who can participate | Inclusion Criteria: * 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) * Ability to understand and the willingness to sign a written informed consent document (or legally authorized representative) * Patient must be a potential hematopoietic stem cell transplant candidat |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Lead sponsor | Fred Hutchinson Cancer Center |
| Locations | Seattle, Washington, United States |
| Start date | 2021-02-09 |
| NCT ID | NCT04370301 |
| Official listing | https://clinicaltrials.gov/study/NCT04370301 |