Axatilimab + Decitabine/Venetoclax for Acute Myeloid Leukemia

SR
CG
Overseen ByCaitlin Guzowski
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Northside Hospital, Inc.
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 combination of treatments—Axatilimab (an experimental treatment), Decitabine, and Venetoclax—to determine their effectiveness in treating acute myeloid leukemia (AML) with a specific genetic change in the TP53 gene. In some individuals with AML, the TP53 gene may be mutated or deleted. This trial targets those who have either not yet received treatment or whose cancer has returned after initial treatment. Individuals diagnosed with AML and a TP53 mutation or deletion may find this trial suitable. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment combination.

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

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Studies have shown that using Venetoclax and Decitabine together is generally safe for treating acute myeloid leukemia (AML). This combination has proven effective and well-tolerated in older patients with AML. Reports indicate that most patients experience manageable side effects, meaning the treatment doesn't cause severe problems for most people.

The trial introduces a new drug called Axatilimab. In this early stage (Phase 1), the focus is primarily on safety. This phase assesses how well patients tolerate the treatment and identifies any side effects. Since it's early, complete safety information for Axatilimab in humans is not yet available. However, testing it with other drugs known to be safe is promising. Researchers will closely monitor participants to ensure their safety.12345

Why are researchers excited about this trial's treatments for AML?

Researchers are excited about the combination of Axatilimab, Decitabine, and Venetoclax for treating Acute Myeloid Leukemia (AML) because it offers a fresh approach compared to existing treatments. Unlike traditional chemotherapy, which broadly attacks both healthy and cancerous cells, this combination targets specific pathways involved in cancer cell survival and growth. Axatilimab is notable for its action on the CSF-1R pathway, potentially reducing the immune system's suppression by the leukemia cells. Decitabine and Venetoclax complement this by disrupting the cancer cells' DNA repair and survival mechanisms. This targeted approach not only aims to be more effective but also may result in fewer side effects, making it an exciting development in AML treatment.

What evidence suggests that this trial's treatments could be effective for acute myeloid leukemia?

Research has shown that using Decitabine and Venetoclax together holds promise for treating acute myeloid leukemia (AML). In one study, 90% of patients achieved complete remission, with no detectable cancer. Another study found these drugs more effective than strong chemotherapy for older patients. In this trial, participants will receive a combination of Axatilimab, Decitabine, and Venetoclax. Adding Axatilimab may enhance the immune system, though limited data exists on this combination. Overall, Decitabine and Venetoclax have demonstrated strong potential in treating AML.35678

Are You a Good Fit for This Trial?

This trial is for people with acute myeloid leukemia (AML) who have a TP53 mutation or deletion. Participants can be newly diagnosed or in their first relapse, but must not have had more than one prior treatment.

Inclusion Criteria

My cancer has a TP53 gene mutation.
My cancer has a TP53 gene deletion.
My bone marrow test shows positive TP53 staining.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Chemotherapy

Participants receive induction chemotherapy with decitabine and venetoclax to achieve MRD-negative complete remission

2 months
Bone marrow biopsies and disease response assessments

Consolidation

Participants undergo consolidation therapy with regular bone marrow biopsies every 3 months

1 year
Regular visits every 3 months for bone marrow biopsies

Follow-up

Participants are monitored for safety, overall survival, and progression-free survival

1 year
Contact for survival data 1 year after completion of therapy

What Are the Treatments Tested in This Trial?

Interventions

  • Axatilimab
  • Decitabine
  • Venetoclax

Trial Overview

The study tests a combination of three drugs—Axatilimab, Decitabine, and Venetoclax—to see how well they work together for treating AML with TP53 mutations or deletions.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Axatilimab+Decitabine+VenetoclaxExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northside Hospital, Inc.

Lead Sponsor

Trials
26
Recruited
1,100+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Citations

Axatilimab Combined With Decitabine/Venetoclax for the ...

Outcomes of TP53-mutant acute myeloid leukemia with decitabine and venetoclax. Cancer. 2021 Oct 15;127(20):3772-3781. doi: 10.1002/cncr.33689. Epub 2021 Jul ...

Efficacy of Venetoclax Combined with Decitabine-Based ...

After a course of venetoclax plus decitabine-based treatment, 9 patients achieved complete remission (CR) and 1 patient achieved complete ...

Meta-analysis on the effectiveness and safety of venetoclax ...

The combined therapy strategy of venetoclax with hypomethylating agents (HMAs) has demonstrated encouraging efficacy in the treatment of acute myeloid leukemia ...

Decitabine + Venetoclax Compared with Intensive ...

Superior outcomes were observed for older patients with AML receiving decitabine + venetoclax for 10 days versus intensive chemotherapy in a propensity ...

Syndax Announces Positive Data for Revumenib in Patients ...

Data to date demonstrate that revumenib has been well tolerated and demonstrated clinical activity in combination with venetoclax/hypomethylating agents.

Axatilimab + Decitabine/Venetoclax for Acute Myeloid ...

This Phase 1 medical study run by Northside Hospital, Inc. needs participants to evaluate whether Axatilimab, Decitabine and Venetoclax will have tolerable ...

Axatilimab Combined With Decitabine/Venetoclax for the ...

Axatilimab combined with Decitabine/Venetoclax for the treatment of TP53-mutated/deleted AML patients.

The efficacy and safety of venetoclax combined with ... - PMC

In summary, our findings demonstrated that the VEN + DEC regimen was effective and safe for treatment of elderly patients with AML. Results of ...