AlloHCT With PegINFa for Myelofibrosis

Study acronym: ATIOM
StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 4 months later Aug 2026 → Jan 2027
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Record History

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  1. Primary completion pushed from Aug 2026 to Jan 2027
    • Eligibility criteria expanded, about 66 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Publications: details revised at 20 of 22 entries
  2. Primary completion date: Apr 2026 to Aug 2026v9 Show 6 more changesShow less
    • Study completion date: Oct 30, 2027 to Mar 2028
    • Eligibility criteria revised
    • Secondary endpoints reordered
    • Site contact updated
    • Study title shortened, about 8 words
    • Collaborators expanded, about 3 words
  3. Primary completion date: Apr 2025 to Apr 2026
    • Start date: Mar 23, 2023 to Aug 2, 2023
    v8
  4. Primary completion date: Oct 30, 2024 to Apr 2025v7
  5. Secondary endpoints: 5 to 6
    • Eligibility criteria expanded, about 5 words
    v6
Show 4 earlier versionsHide 4 earlier versions
  1. Re-verified, no change to tracked fieldsv5
  2. Trial status: Suspended to Recruiting
    • Start date changed from estimate of Feb 2023 to Mar 23, 2023
    • Secondary endpoints: details revised at 1 of 5 entries
    • Site details revised
    v4
  3. Trial status: Not Yet Recruiting to Suspended Sponsor's reason: amendment pending
    • Start date: Jan 30, 2023 to Feb 2023
    v3
  4. Start date: Oct 30, 2022 to Jan 30, 2023v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05535764
Lead Sponsor University of Utah
Collaborators: Huntsman Cancer Institute
Conditions
(from sponsor)		 Myelofibrosis
Related terms Primary Myelofibrosis
Enrollment 18 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov