Study on Oral Combination Treatment for Acute Myeloid Leukemia (AML)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05360160

Provider View

This clinical trial is testing a new combination of oral medications to find the best dose and see if it can help control acute myeloid leukemia (AML) or a similar type of leukemia. The study involves two parts: finding the right dose and testing its effectiveness.

Patient Parameters

Program Overview

The study is divided into two parts. Part 1b aims to find the highest dose of the new drug SNDX-5613 that can be safely combined with other oral medications, ASTX727 (a mix of decitabine and cedazuridine) and venetoclax, for patients with acute myeloid leukemia (AML) or a similar type of leukemia. Part 2 will test if this combination can effectively control the disease.

Description

The main goals of this study are to determine the safety and best dose of the new drug combination for patients with acute myeloid leukemia (AML) and to see how well it works in controlling the disease. The study will also look at how long patients live without the disease getting worse and how long the treatment response lasts. Additionally, researchers will explore specific markers in the body that might predict how well the treatment works or if there is any resistance to it.

Eligibility Criteria

Inclusion Criteria

  • Age 12 years or older and weigh at least 40 kg.
  • Good overall health with a performance status score of 2 or less.
  • Newly diagnosed or relapsed/refractory AML or similar leukemia with specific genetic markers (KMT2Ar, NUP98r, or NPM1c).
  • White blood cell count below 25,000/µL at enrollment. Cytoreduction allowed before enrollment.
  • Heart function with an ejection fraction over 40%.
  • Adequate liver function with specific bilirubin and enzyme levels.
  • Adequate kidney function with creatinine clearance of 60 mL/min or higher.
  • Willing to provide informed consent.
  • At least 14 days since last treatment for non-rapidly growing disease, or 5 half-lives of prior therapy. Certain medications allowed for rapidly growing disease.
  • Women of childbearing potential must use effective contraception during the study and for 3 months after. Men must be sterile or use contraception during the study and for 3 months after.

Exclusion Criteria

  • Previous treatment with a menin inhibitor.
  • Uncontrolled medical, laboratory, or psychiatric conditions that pose a risk.
  • Use of other cancer treatments during the study, except for specific exceptions.
  • Severe gastrointestinal or metabolic conditions affecting medication absorption.
  • Active cancer under treatment.
  • Active hepatitis B, hepatitis C, or HIV infection.
  • Pregnant or breastfeeding women.
  • Active uncontrolled infection.
  • Recent serious heart conditions or strokes.
  • Abnormal heart rhythm (QTc) measurements.
  • Conditions that might interfere with study results or participation.
  • Active central nervous system leukemia.
  • On immunosuppressive therapy post-transplant with relapsed/refractory leukemia.
  • Active graft-versus-host disease (GVHD) of certain severities.

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