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Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation

StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Oct 31, 2027 → Oct 31, 2029
Primary endpoint added 1 → 2 primary endpoints
See other at-risk trials from Sawa Ito, MD

Record History

  1. Primary endpoint(s) modified Trial arms changed: 1 → 2 · Study description expanded, about 42 wordsv8 Show 2 more changesShow less
    • Trial arms changed: 1 → 2
    • Study description expanded, about 42 words

    See this version in full on ClinicalTrials.gov ↗

  2. Primary and study completion pushed from Oct 31, 2027 to Oct 31, 2029 Enrollment increased: 45 → 57 participants · Eligibility criteria expanded, about 60 wordsv7 Show 2 more changesShow less
    • Enrollment increased: 45 → 57 participants
    • Eligibility criteria expanded, about 60 words

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 2 to 3 Eligibility criteria expanded, about 76 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 76 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Aug 22, 2024 to Sep 23, 2024 Study sites: 1 to 2v5 Show 1 more changeShow less
    • Study sites: 1 to 2
  5. Primary completion date: Aug 31, 2026 to Oct 31, 2027 Completion date: Aug 31, 2027 to Oct 31, 2027 · Collaborators: 2 to 3v4 Show 2 more changesShow less
    • Completion date: Aug 31, 2027 to Oct 31, 2027
    • Collaborators: 2 to 3

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Re-verified, no change to tracked fieldsv3
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 31, 2024 to Aug 22, 2024 · Site details revisedv2 Show 2 more changesShow less
    • Start date: Aug 31, 2024 to Aug 22, 2024
    • Site details revised
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 phase 2 study aims to confirm the efficacy observed in the prior phase 1 trial in Cohort 1 and to evaluate the safety of IFN-γ in combination with DLI in Cohort 2, the haploidentical donor alloSCT recipient cohort. The study will further contribute to this effort through the collection of leukemia cells pre- and post-in vivo IFN-γ therapy. As in the previously conducted phase 1 trial, this trial will assess whether leukemia blasts are responsive to IFN-γ in vitro and in vivo. Single-cell RNA sequencing (scRNAseq) will be performed to evaluate transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Trial Details
NCT Number NCT06529731
Lead Sponsor Sawa Ito, MD
Collaborators: Evans MDS Discovery Research Grant, Amgen, FDA Office of Orphan Products Development
Conditions Acute Myeloid Leukemia, Myelodysplastic Syndromes
Enrollment 57 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov