Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis
NCT05535764 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2025-05-07
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.
Conditions
Interventions
- DRUG
-
Pegylated interferon alpha2a
PegINFa will be given once every 2 weeks by subcutaneous administration in the abdomen or thigh.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Sagar Patel, MD · Huntsman Cancer Institute
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-08-02
- Primary Completion
- 2026-04-30
- Completion
- 2027-10-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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