AlloHCT With PegINFa for Myelofibrosis

Part of paid clinical trials in Salt Lake City, Utah.

Sponsor
University of Utah
Study ID
NCT05535764
Phase
PHASE1
Status
Recruiting
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Conditions

  • Myelofibrosis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pegylated interferon alpha2a — DRUG
    PegINFa will be given once every 2 weeks by subcutaneous administration in the abdomen or thigh.

Study Details

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.

Key Dates

Start date
Aug 2, 2023
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Mar 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment: All Patients
    A 3+3 dose de-escalation design will be used to determine the recommended phase 2 dose,while ensuring the safety and tolerability of the treatment. In this trial, the dose determined to be the maximum tolerated dose will be the recommended phase 2 dose and will be utilized in the cohort expansion.

Primary Outcome Measure

Rate of dose-limiting toxicities (DLTs) during the DLT evaluation period [ Time Frame: Start of treatment to 86 days after treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Huntsman Cancer Institute at the University of UtahSalt Lake CityUtah84112
Rachel Kingsford
[email protected]
801-585-0115
Sagar Patel, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Salt Lake City, UT

By research site
Huntsman Cancer Institute at the University of Utah· Salt Lake City, UT

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