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AZA + APG1252 for High-Risk AML

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
Disqualifiers: Pregnancy, Uncontrolled illness, CNS leukemia, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This is a phase Ib/II study that aims to investigate the safety, tolerability and explore the efficacy of BCL- XL inhibition in participants with high-risk AML.

Who Is on the Research Team?

TK

Tapan Kadia, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

Inclusion Criteria

My liver, kidney, and heart function are within the required healthy ranges.
I am able to care for myself and do light activities.
6. A negative urine pregnancy test is required within 1 week for all women of childbearing potential prior to enrolling on this trial.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lead-In Treatment

Participants receive Azacitidine and APG1252 to evaluate safety and tolerability

4 weeks
Inpatient or outpatient basis at MD Anderson Cancer Center

Phase II Treatment

Participants receive Azacitidine and APG1252 to evaluate efficacy in terms of ORR

4 weeks per cycle, repeated as needed
Inpatient or outpatient basis at MD Anderson Cancer Center

Follow-up

Participants are monitored for safety, tumor response, and symptom relief

Through study completion; an average of 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • APG1252
  • Azacitidine

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Lead-In: Part I Lead-In Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimental Treatment2 Interventions
Group II: Cohort B: Part II Cohort B Treatment with Azacitidine (IV or SQ)+APG1252 (IV) Q4W untreated AMLExperimental Treatment2 Interventions
Group III: Cohort A: Part II Cohort A Treatment with Azacitidine (IV or SQ) + APG1252 (IV) Q4W R/R AMLExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

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