Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia (NCT03983824)

🧪 Interventions in This Study

• Cytarabine (DRUG)
• Etoposide Phosphate (DRUG)
• Mitoxantrone Hydrochloride (DRUG)
• Peposertib (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. An established and confirmed diagnosis of AML by World Health Organization criteria, excluding acute promyelocytic leukemia (APL) (with promyelocytic leukemia -retinoic acid receptor alpha \[PML-RARA\])
2. Patients with R/R AML, defined as:
3. Relapsed: \>= 5% bone marrow blasts by morphology, reappearance of peripheral blood blasts, or development of extramedullary leukemia after achieving prior CR or CRi. First or second relapse is eligible. First relapse is restricted to participants with CR 1 duration of less than 9-12 months
4. Refractory: no CR or CRi after one or more cycles of induction. Induction cycles include regimens with the intent to achieve remission and can include high intensity and/or low intensity regimens
5. Age \>= 18 years. Because no dosing or adverse event data are currently available on the use of M3814 in combination with mitoxantrone, etoposide, and cytarabine in patients \< 18 years of age, children are excluded from this study, but will be eligible for future pediatric trials
6. Eastern Cooperative Oncology Group (ECOG) performance status =\< 1 (or Karnofsky \>= 60%)
7. Serum bilirubin =\< 1.5 institutional upper limit of normal (ULN) (For patients with hemolysis, Gilbert's syndrome or liver infiltration with leukemia, serum bilirubin =\< 3 x institutional ULN)
8. Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) =\< 3 x institutional ULN (For patients with liver infiltration with leukemia, AST\[SGOT\]/ALT\[SGPT\] =\< 5 x institutional ULN)
9. Glomerular filtration rate (GFR) \>= 60 mL/min/1.73 m\^2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
10. Patients must be medically eligible to receive MEC, including acceptable pre-study cardiac function (left ventricular ejection fraction of \>= 45%) and lifetime anthracycline exposure (=\< 360 mg/m\^2 daunorubicin equivalents)
11. Patients may have had prior allogeneic hematopoietic cell transplant at least 3 months prior to enrollment but should not have evidence of active graft versus host disease or require systemic immune suppression
12. Patients must be willing to submit the blood sampling and bone marrow sampling for any mandatory PK and pharmacodynamics analyses and exploratory biomarkers

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (15 Sites)

• City of Hope Comprehensive Cancer Center — Duarte, California
• Los Angeles General Medical Center — Los Angeles, California
• USC / Norris Comprehensive Cancer Center — Los Angeles, California
• USC Norris Oncology/Hematology-Newport Beach — Newport Beach, California
• Keck Medical Center of USC Pasadena — Pasadena, California
• University of California Davis Comprehensive Cancer Center — Sacramento, California
• UM Sylvester Comprehensive Cancer Center at Coral Gables — Coral Gables, Florida
• UM Sylvester Comprehensive Cancer Center at Deerfield Beach — Deerfield Beach, Florida
• University of Miami Miller School of Medicine-Sylvester Cancer Center — Miami, Florida
• UM Sylvester Comprehensive Cancer Center at Plantation — Plantation, Florida
• Beth Israel Deaconess Medical Center — Boston, Massachusetts
• Mount Sinai Hospital — New York, New York
• University of Cincinnati Cancer Center-UC Medical Center — Cincinnati, Ohio
• University of Cincinnati Cancer Center-West Chester — West Chester, Ohio
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma

📞 Contact the Study Coordinator

Phone: (800) 826-4673

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

• 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
• Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
• Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Recurrent Acute Myeloid Leukemia

• Navitoclax, Venetoclax, and Decitabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Previously Treated With Venetoclax — Duarte, California
• Liposome-encapsulated Daunorubicin-Cytarabine and Venetoclax in Treating Participants With Relapsed, Refractory or Untreated Acute Myeloid Leukemia — Houston, Texas
• A Phase 1 Study of AOH1996 in Patients With Relapsed/Refractory Acute Myeloid Leukemia — Duarte, California
• Azacitidine, Venetoclax, and Gilteritinib in Treating Patients With Recurrent/Refractory FLT3-Mutated Acute Myeloid Leukemia, Chronic Myelomonocytic Leukemia, or High-Risk Myelodysplastic Syndrome/Myeloproliferative Neoplasm — Houston, Texas
• Enasidenib for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With an IDH2 Mutation — Birmingham, Alabama
• BSB-2002 After Cyclophosphamide and Fludarabine for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia Patients With NPM1 Mutation — Duarte, California

Explore by condition: All Recurrent Acute Myeloid Leukemia clinical trials

💡 How to Participate

1. Check the checklist above to see if you may qualify.
2. Contact the study coordinator using the phone/email above.
3. Ask about the visit schedule, what is covered at no cost, and any travel support.
4. Confirm with your own doctor before making a decision.