A Phase Ib Study of Rezatapopt in Combination With Azacitidine in Patients With TP53Y220C Mutant Myeloid Malignancies (Acute Myeloid Leukemia or Myelodysplastic Syndrome) (NCT06616636)

🧪 Interventions in This Study

• Azacitidine (DRUG)
• Rezatapopt (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. Patient is ≥ 18 years of age at the time of signing the informed consent form (ICF).
2. Patient is willing and able to adhere to the study visit schedule and other protocol requirements.
3. Patient has relapsed or primary refractory AML or MDS
4. Any other comorbidity that per the investigator renders a patient inappropriate for intensive chemotherapy.
5. Patients with MDS must be classified as MDS-IB1 or IB2 as per WHO 2022 criteria32
6. TP53Y220C mutation confirmed by CLIA-approved local testing with a variant allele frequency \>2%.
7. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
8. Patient has adequate organ function defined as:
9. Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.
10. Serum total bilirubin ≤ 1.5 x ULN. Higher levels are acceptable if these can be attributed to ineffective erythropoiesis, leukemia organ involvement or Gilbert\'s syndrome.
11. Serum creatinine \< 2 x ULN or creatinine clearance \> 40 mL/min based on validated glomerular filtration rate (GFR) estimation (Cockcroft-Gault, CKD-epi, or MDRD equations).
12. Females of childbearing potential may participate provided they have a negative serum or urine pregnancy test at screening and a negative serum OR urine pregnancy test within 72 hours of starting on treatment. They also must agree to either abstain from sexual intercourse or use two forms of a highly effective method of contraception while on study and up to 3 months after the last dose of the study drug.

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

📍 All Participating Trial Locations (2 Sites)

• Moffitt Cancer Center — Tampa, Florida
• The University of Texas MD Anderson Cancer Center — Houston, Texas

📞 Contact the Study Coordinator

Phone: (713) 794-1141

Email: cdinardo@mdanderson.org

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 Myelodysplastic Syndrome

• A Safety Study of SEA-CD70 in Patients With Myeloid Malignancies — Birmingham, Alabama
• Revisiting the Universal Donor: Does Exposure to O Blood Products Affect Patient Outcomes? — Hamilton, Ontario
• Study of a Geriatric Assessment to Plan a Treatment Approach for Older People With Various Blood Disorders — Basking Ridge, New Jersey
• Testing the Addition of an IDH2 Inhibitor, Enasidenib, to Usual Treatment (Cedazuridine-Decitabine) for Higher-Risk Myelodysplastic Syndrome (MDS) With IDH2 Mutation (A MyeloMATCH Treatment Trial) — Berkeley, California
• A Study to Compare Elritercept With Epoetin Alfa to Treat Anemia in Adults With Very Low, Low, or Intermediate Risk Myelodysplastic Syndromes (MDS) Who Need Regular Blood Transfusions — Gilbert, Arizona

Explore by condition: All Myelodysplastic Syndrome 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.