RecruitingPhase 1NCT05535764

AlloHCT With PegINFa for Myelofibrosis

Allogeneic Hematopoietic Cell Transplantation With Pegylated Interferon Alfa-2a for Primary and Secondary Myelofibrosis (ATIOM)

Sponsor

University of Utah

Enrollment

18 participants

Start Date

Aug 2, 2023

Study Type

INTERVENTIONAL

Conditions

Myelofibrosis

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 1 clinical trial is testing whether pegylated interferon alfa-2a — an immune-modulating drug — can be safely given after a bone marrow transplant (allogeneic HCT) to improve long-term outcomes for adults with myelofibrosis, a bone marrow disease. The drug is being added to the standard post-transplant care regimen in a dose-finding study, with an expansion group to follow. Adults aged 18 and older with primary or secondary myelofibrosis who have undergone a matched donor bone marrow transplant and are approximately 50 to 80 days post-transplant with adequate organ function may be eligible. Participation involves receiving the study drug by injection over several months with regular clinic visits, blood tests, and bone marrow biopsies. This summary was prepared to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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