Actively Recruiting
MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Led by City of Hope Medical Center · Updated on 2026-04-15
12
Participants Needed
1
Research Sites
75 weeks
Total Duration
On this page
Sponsors
C
City of Hope Medical Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
MiRisten for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent by participant or legally authorized representative
- Agreement to use archival tissue from diagnostic tumor biopsies or approval for exception by study PI
- Age 18 years or older
- ECOG performance status of 0, 1, or 2
- Histologically confirmed relapsed or refractory AML per ICC or WHO criteria who have failed or are ineligible for available AML therapies
- Patients with extramedullary disease may be included if marrow disease is also present
- Fully recovered from acute toxic effects of prior anti-cancer therapy except alopecia, at grade 1 or lower
- Life expectancy of at least 3 months
- Total bilirubin less than or equal to 1.5 times upper limit of normal within 28 days prior to treatment
- AST less than or equal to 3 times upper limit of normal within 28 days prior to treatment
- ALT less than or equal to 3 times upper limit of normal within 28 days prior to treatment
- Creatinine clearance of at least 60 mL/min within 28 days prior to treatment
- INR or PT less than or equal to 1.5 times upper limit of normal within 28 days prior to treatment
- aPTT less than or equal to 1.5 times upper limit of normal within 28 days prior to treatment
- Left ventricular ejection fraction of at least 45% within 28 days prior to treatment
- Corrected QT interval (QTcF) less than or equal to 480 ms within 28 days prior to treatment
- Negative pregnancy test for women of childbearing potential within 28 days prior to treatment
- Agreement by men and women of childbearing potential to use effective birth control or abstain through study and for 3 months after last dose
You will not qualify if you...
- Allogeneic hematopoietic stem cell transplant within 3 months prior to treatment
- Use of calcineurin inhibitors within 2 weeks prior to treatment
- Chemotherapy, radiation, biological therapy, or immunotherapy within 14 days prior to treatment except hydroxyurea
- Use of strong or moderate CYP3A4 inducers or strong CYP3A inhibitors (except azole antifungals) within 7 days prior to treatment
- Use of foods or supplements that strongly affect CYP3A within 3 days prior to and during treatment
- Systemic steroid therapy above 10 mg/day prednisone equivalent within 14 days prior to treatment (except low-dose or topical steroids)
- Receipt or planned receipt of live vaccines during study or 28 days before or after treatment
- Diagnosis of acute promyelocytic leukemia
- History of allergic or infusion reactions to compounds similar to study drug
- Inability to tolerate prescribed dexamethasone doses
- Unstable cardiac disease including unstable angina, uncontrolled atrial fibrillation or hypertension, recent acute coronary syndrome or revascularization within 6 months
- Clinically significant uncontrolled illness or active infection
- Other active malignancies that may interfere with study safety or efficacy evaluation
- Pregnant or breastfeeding females
- Any other condition or circumstance that would contraindicate participation or compliance with study procedures according to investigator judgment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
City of Hope Medical Center
Duarte, California, United States, 91010
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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