Bleximenib + Venetoclax + Azacitidine for Acute Myeloid Leukemia
(cAMeLot-2 Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether combining new and existing treatments benefits people with Acute Myeloid Leukemia (AML) who have specific gene mutations. Participants will receive either bleximenib (a new potential drug) with venetoclax and azacitidine or a placebo with venetoclax and azacitidine. The aim is to determine if the combination with bleximenib is more effective. Suitable candidates include those with newly diagnosed AML who cannot undergo intensive chemotherapy, particularly if they have certain gene changes or severe health issues. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the combination of bleximenib, venetoclax, and azacitidine has delivered promising results in earlier studies. Patients with relapsed or hard-to-treat Acute Myeloid Leukemia (AML) demonstrated a high response rate of 82%, indicating that most experienced positive effects from the treatment.
Regarding safety, this combination has been well-tolerated by patients. Previous studies indicate that the safety levels are acceptable, suggesting that most can undergo the treatment without severe side effects. However, like any treatment, some side effects might occur, so discussing these with a healthcare provider is important.
The current study is in its advanced stages, indicating that the treatment has passed earlier safety checks. This can offer reassurance about its safety for those considering joining the trial.12345Why are researchers excited about this trial's treatments?
Researchers are excited about this treatment combination for acute myeloid leukemia (AML) because it introduces Bleximenib, a novel agent that targets cancer cell growth differently. Most treatments for AML, like chemotherapy and certain targeted therapies, focus on killing fast-dividing cells or blocking specific proteins. However, Bleximenib acts on a unique pathway that may enhance the effectiveness of Venetoclax and Azacitidine. This innovative approach could potentially improve outcomes for patients with AML, offering hope for better control of the disease.
What evidence suggests that this trial's treatments could be effective for Acute Myeloid Leukemia?
In this trial, participants with Acute Myeloid Leukemia (AML) will be assigned to different treatment arms. Arm A will receive Bleximenib combined with Venetoclax (VEN) and Azacitidine (AZA). Previous studies have shown that adding Bleximenib to VEN and AZA yields promising results for treating AML, proving more effective at combating leukemia than VEN and AZA alone. Research suggests this combination may be particularly effective for patients with specific genetic changes in the NPM1 or KMT2A genes. Additionally, the safety profile of the combination mirrors that of VEN and AZA alone, indicating no significant increase in side effects. While these findings are promising, further research is needed to fully confirm its effectiveness. Arm B will receive a placebo with VEN and AZA, serving as a comparator to evaluate the effectiveness of the Bleximenib combination.13467
Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with previously untreated Acute Myeloid Leukemia (AML) that have specific genetic changes. They must have good liver and kidney function, not be pregnant or breastfeeding, agree to use contraception, and understand the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Bleximenib with Venetoclax and Azacitidine or Placebo with Venetoclax and Azacitidine in 28-day cycles until progression or unacceptable toxicity
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Bleximenib
- Venetoclax
Find a Clinic Near You
Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University