MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Part of paid clinical trials in Duarte, California.
- Sponsor
- City of Hope Medical Center
- Study ID
- NCT07025564
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Recurrent Acute Myeloid Leukemia
- Refractory Acute Myeloid Leukemia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Biospecimen Collection — PROCEDUREUndergo bone marrow and blood sample collection
- Echocardiography Test — PROCEDUREUndergo ECHO
- miR-126 Inhibitor miRisten — DRUGGiven IV
Study Details
This phase I trial tests the safety, side effects, and best dose of miRisten in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). MiRisten may stop the growth of cancer cells by blocking some of the molecules needed for cell growth. Giving miRisten may be safe, tolerable and/or effective in treating patients with relapsed or refractory AML.
Key Dates
- Start date
- Oct 24, 2025
- Status verified
- Jun 2026
- Primary completion
- Mar 1, 2028
- Completion
- Aug 1, 2028
Study Design
- Enrollment
- 12 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Treatment (miRisten)Patients receive miRisten IV over 30 minutes BID on days 1-5, 8-12 and 15-19 in the absence of disease progression or unacceptable toxicity. Patients also undergo ECHO during screening and bone marrow and blood sample collection throughout the trial.
Primary Outcome Measure
Incidence of adverse events (AEs) [ Time Frame: Up to 30 days after completion of study treatment ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| City of Hope Medical Center | Duarte | California | 91010 | Amanda Blackmon (PRINCIPAL_INVESTIGATOR) |
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