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Phase Ib Rezatapopt and Azacitidine for TP53Y220C Mutant Myeloid Cancers

This study is testing a new combination treatment for people with certain blood cancers, specifically Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS), who have a specific gene change called TP53Y220C. The treatment involves two drugs: Azacitidine, given through a vein (IV), and Rezatapopt, taken by mouth with food. The main goal is to see how safe this combination is and what side effects it might cause. Researchers also want to see if the treatment is effective. You might be able to join if you are 18 or older, have relapsed or difficult-to-treat AML or MDS with the TP53Y220C gene change, and are not suitable for intensive chemotherapy. The study plans to enroll about 24 participants, but its current status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is a Phase Ib study, which typically focuses on safety and dosage, and plans to enroll 24 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and adverse events will be measured through study completion, which is an average of 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06616636

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
M.D. Anderson Cancer Center
~24 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:AzacitidineRezatapopt

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and adverse events (AEs)
Measured over Through study completion; an average of 1 year

Conditions

Myelodysplastic Syndrome
Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaMyelodysplastic SyndromeTP53 Gene

Where it's being run

2 sites across 2 states
Florida1
Texas1

Study leadership

  • Courtney DiNardo, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center

Who to contact

Courtney DiNardo, MD
[email protected]
(713) 794-1141
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 3 x ULN, unless considered due to leukemic organ involvement.
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.
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). 9. 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. 10. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) 14 days prior to study entry and for the duration of study participation. This includes all female patients between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:

What this trial measures

  • Safety and adverse events (AEs)Through study completion; an average of 1 year

    Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0