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NCT06529731 · ClinicalTrials.gov registry record · Phase 2
Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Sawa Ito, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 45
- Enrollment target
- 3
- Study locations
NCT06529731: Recruiting Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, sponsored by Sawa Ito, MD.
NCT06529731 is a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes that is actively recruiting participants, run by Sawa Ito, MD. The registered enrollment target is 45 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06529731, a Phase 2 study of Acute Myeloid Leukemia and Myelodysplastic Syndromes, is actively recruiting participants, sponsored by Sawa Ito, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 45 participants
- Enrollment target
- 3
- Study locations
Study Summary
This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and 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 test whether leukemia blasts were responsive to IFN-γ in vitro and in vivo, with single-cell RNA sequencing (scRNAseq) conducted to understand the transcriptomic changes induced by IFN-γ in leukemia cell subsets, including those with stem cell characteristics.
Primary Outcome
Cohort 1: Occurrence of treatment failure, hematologic relapse from a CR (complete remission)/CRh/Cri), or death observed from start of IFN-γ treatment. Patients alive at 1 year after start of treatment will be censored on the date of last contact.
Conditions Studied
Interventions
- DRUG Interferon gamma-1b
- BIOLOGICAL Donor Leukocyte Infusion (DLI)
Study Locations (3)
Missouri
- Washington University - St Louis
Pennsylvania
- UPMC Hillman Cancer Center - Pittsburgh
Washington
- Fred Hutchinson Cancer Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2024-09-23 |
| Est. Completion | 2027-10-31 |
| Phase | Phase 2 |
What NCT06529731 shows while recruiting
NCT06529731 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (61% lower).
The record links to 2 conditions, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which Interferon gamma-1b is the first listed.
NCT06529731 reports a single indexed study location in Missouri, Pennsylvania, Washington.
Frequently Asked Questions
What is clinical trial NCT06529731 about?
NCT06529731 is a clinical study titled "Interferon-γ (IFN-γ) With Donor Leukocyte Infusion to Treat Relapsed Acute Myeloid Leukemia and Myelodysplastic Syndromes Post Allogeneic Hematopoietic Stem Cell Transplantation". This phase 2 study aims to confirm the efficacy seen in the prior phase 1 trial, and 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 test whether leukemia blasts were respon...
What is the current status of trial NCT06529731?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 45 participants. The study started on 2024-09-23. Estimated completion is 2027-10-31.
What conditions does trial NCT06529731 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia, Myelodysplastic Syndromes.
What interventions are being tested in trial NCT06529731?
The interventions under investigation include: Interferon gamma-1b (DRUG), Donor Leukocyte Infusion (DLI) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06529731?
This trial is sponsored by Sawa Ito, MD, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06529731 being conducted?
This trial has 3 study locations across Missouri, Pennsylvania, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06529731's enrollment target sits among peer trials
45 158th of 306 higher than 145 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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