Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis (ATIOM)
University of Utah
Summary
This is a single site, open-label, dose de-escalation, Phase 1 study of pegylated interferon alfa-2a administered after alloHCT in subjects with primary or secondary myelofibrosis. Part 1 of the study will assess the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period and identify the Recommended Phase 2 Dose (RP2D). Once the RP2D is identified, 6 additional patients will be enrolled in the expansion cohort.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Pre-Transplant Inclusion Criteria (Step 1) * Male or female subject aged ≥ 18 years. * Diagnosis of primary or secondary myelofibrosis. * Eligible to undergo a myeloablative or reduced intensity conditioning regimen (MAC or RIC) * Eligible to undergo a standard of care bone marrow biopsy with aspirate as part of his or her routine pre-transplant work-up. * Peripheral blood stem cell (PBSC) graft * 10/10 HLA matched related or matched unrelated donor * ECOG performance status ≤ 2. * For female subjects: Negative pregnancy test or evidence of post-menopausal status. The pos…
Interventions
- DrugPegylated interferon alpha2a
PegINFa will be given once every 2 weeks by subcutaneous administration in the abdomen or thigh.
Location
- Huntsman Cancer Institute at the University of UtahSalt Lake City, Utah