Axatilimab + Decitabine/Venetoclax for Acute Myeloid Leukemia
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.12345Why 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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Induction Chemotherapy
Participants receive induction chemotherapy with decitabine and venetoclax to achieve MRD-negative complete remission
Consolidation
Participants undergo consolidation therapy with regular bone marrow biopsies every 3 months
Follow-up
Participants are monitored for safety, overall survival, and progression-free survival
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Northside Hospital, Inc.
Lead Sponsor
Incyte Corporation
Industry Sponsor
Steven Stein
Incyte Corporation
Chief Medical Officer since 2015
MD from University of Witwatersrand
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 ...
4.
theoncologypharmacist.com
theoncologypharmacist.com/special-issues/2020-year-in-review-aml/decitabine-venetoclax-compared-with-intensive-chemotherapy-in-aml-a-propensity-score-matched-analysisDecitabine + 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 ...
5.
ir.syndax.com
ir.syndax.com/news-releases/news-release-details/syndax-announces-positive-data-revumenib-patients-acuteSyndax 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 ...
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