52 Participants NeededMy employer runs this trial

AZA + APG1252 for High-Risk AML

Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: M.D. Anderson Cancer Center
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 trial explores a new treatment for individuals with high-risk acute myeloid leukemia (AML), a cancer affecting blood and bone marrow. The trial tests a combination of two drugs, APG1252 (a potential new drug) and Azacitidine, to assess their safety and effectiveness together. Participants are divided into groups: one for those whose AML has returned or not responded to other treatments, and another for those newly diagnosed with AML. Individuals with frequent AML relapses or a new diagnosis may be suitable for this trial. As a Phase 1, Phase 2 trial, the research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor to get specific guidance based on your situation.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that azacitidine, when combined with other treatments, is generally safe for patients with acute myeloid leukemia (AML). Specifically, studies have found that pairing azacitidine with venetoclax can slow disease progression and is well-tolerated by patients, meaning they can undergo treatment without severe side effects.

Conversely, APG1252 is a newer treatment still under investigation. This trial is in its early stages, focusing on the safety of APG1252 for individuals. Since the research is in its infancy, the primary goal is to observe patient reactions and identify any side effects.

In summary, early research suggests azacitidine is generally safe, while the safety of APG1252 remains under study. Trial participants will be closely monitored to ensure their safety remains a top priority.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Azacitidine and APG1252 for high-risk acute myeloid leukemia (AML) because it offers a novel approach compared to standard treatments like chemotherapy. APG1252 is a new agent that targets specific proteins involved in cell death, potentially making it more effective at killing cancer cells. Combining this with Azacitidine, which is already used to treat AML by affecting DNA and RNA, could enhance the overall treatment effectiveness and provide hope for patients who have relapsed or have not been treated before. This innovative combination has the potential to improve outcomes by working synergistically to attack cancer cells in multiple ways.

What evidence suggests that this trial's treatments could be effective for high-risk AML?

This trial will evaluate the combination of Azacitidine and APG1252 for high-risk acute myeloid leukemia (AML). Research has shown that azacitidine, when combined with other treatments, can improve outcomes for AML patients. For example, combining azacitidine with venetoclax reduced the risk of disease progression by 39%. Patients receiving this combination lived longer without disease progression and responded better than those receiving traditional chemotherapy. APG1252, a newer treatment in this trial, targets a protein called BCL-XL, which aids cancer cell survival, suggesting it could complement azacitidine effectively. Early studies indicate that similar combinations are promising and have manageable safety profiles.14678

Who Is on the Research Team?

TK

Tapan Kadia, MD

Principal Investigator

UT MD Anderson

Are You a Good Fit for This Trial?

This trial is for adults (18+) with high-risk or relapsed/refractory acute myeloid leukemia (AML), including certain subtypes and those who have had prior therapy. Participants need good liver, kidney, and heart function, must be able to consent, and women of childbearing age need a negative pregnancy test.

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.
See 7 more

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

Trial Overview

The study tests the safety and effectiveness of combining two drugs—Azacitidine (AZA) and APG1252—in people with high-risk AML. It is an early-phase clinical trial designed to find out how well this drug combination works and what side effects may occur.

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+

Citations

Azacitidine in combination with HAG for newly diagnosed and ...

The median OS was 14.9 months. This may imply that azacitidine combined with HAG can provide both newly diagnosed or relapsed/refractory AML ...

Live from ASCO 2024 | Updated Data of Bcl-2 Inhibitor ...

This poster presents follow-up safety and efficacy data from a Phase Ib/II study of lisaftoclax combined with AZA in adults with AML.

High efficacy of Azacitidine plus HAG in acute myeloid leukemia

The median overall survival (OS) and relapse-free survival (RFS) in ND AML were 22.8 m and not reached, respectively, which were longer than R/R ...

Azacitidine Plus Venclexta Superior to Chemo in Acute AML

In the trial, patients receiving azacitidine/Venclexta had a 39% reduction in risk of progressive disease, persistent disease prompting therapy ...

Advances in Acute Myeloid Leukemia Explored at ASH 2025

Patients treated with azacitidine-venetoclax had a better median event-free survival (14.6 months vs 6.2 months), a higher response rate (88% vs ...

Live from ASCO 2024 | Updated Data of Bcl-2 Inhibitor ...

Among patients with TN AML treated with lisaftoclax combined with AZA, the ORR was 64.1%, and the CRc was 51.3%. In the 600 mg cohort (n=29), ...

press release

ICT01 in combination with azacitidine and venetoclax (Aza-Ven) achieves unprecedented high remission rates overall and across molecular ...

8.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40675138

Comparative Safety and Effectiveness of Azacitidine plus ...

Conclusion: Among AML patients aged 60-75, HMA&Ven showed similar 1-year all-cause mortality compared to IC, while offering a significantly ...