Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML) (NCT07223814)
Bleximenib or Placebo in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for the Treatment of Patients With Newly Diagnosed KMT2A-rearranged or NPM1-mutant Acute Myeloid Leukemia Eligible for Intensive Chemotherapy: a Double-blind Phase 3 Study
🩺 Plain-English Summary (8th-Grade Level)
The current standard of care treatment for adult patients with acute myeloid leukemia (AML) consists of chemotherapy and, if indicated, donor stem cell transplantation. Bleximenib blocks the interaction between a protein called menin and another protein called KMT2A in the leukemia cells. When this interaction is disrupted in AML with mutations in the NPM1 or KMT2A gene, bleximenib can cause leukemia cells to die. The main objective is to assess if treatment with bleximenib, when added to chemotherapy treatment will improve treatment outcome in adult participants with newly diagnosed AML who present with mutations in the NPM1 or KMT2A genes. This is a randomized, double-blind, placebo-controlled, phase 3 clinical trial. All of the participants will receive standard chemotherapy treatment, combined with either bleximenib or a placebo. A placebo is a substance that looks like the study medicine but has no active ingredients (e.g., a sugar pill). In a double blind trial neither the participant nor the doctor know if placebo or active study drug is given. After the end of the protocol treatment there will be an observational follow-up of 4 years from the time of inclusion of the last patient. The results of the different treatment groups will be compared. 875 previously untreated patients with AML with a specific change in the DNA of the leukemia cells (a KMT2A rearrangement or a NPM1 mutation) will be included. Participants must be 18 years or older and considered eligible for intensive chemotherapy.
Who can join: Review the eligibility criteria below.
Location: US-San Francisco CA-UCSF — San Francisco, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (63 Sites)
Showing the first 25 of 63 sites.
- US-San Francisco CA-UCSF — San Francisco, California
- US-Orlando FL-ORLANDOHEALTH — Orlando, Florida
- US-Atlanta GA-EMORY — Atlanta, Georgia
- US-Chigago IL-UHCHICAGO — Chicago, Illinois
- US-Kansas City KS-KUMC — Kansas City, Kansas
- US-Baltimore MD-UMGCCC — Baltimore, Maryland
- US-St Louis MO-WASHU — St Louis, Missouri
- US-Cincinnati OH-CINCY — Cincinnati, Ohio
- AU-Adelaide-FLINDERS — Adelaide,
- AU-Adelaide-RAH — Adelaide,
- AU-Birtinya-SUNSHINECOAST — Birtinya,
- AU-Brisbane-PAH — Brisbane,
- AU-Camperdown-RPA — Camperdown,
- AU-Melbourne-AUSTIN — Melbourne,
- AU-Melbourne-MONASH — Melbourne,
- AU-Melbourne-PMCC — Melbourne,
- AU-Sydney-WSAH — Sydney,
- BE-Antwerpen-UZA — Antwerp,
- BE-Antwerpen-ZAS — Antwerp,
- BE-Brugge-AZBRUGGE — Bruges,
- BE-Brussel-BORDET — Brussels,
- Be-Charleroi-GHDC — Charleroi,
- BE-Geel-STDIMPNA — Geel,
- BE-Gent-UZGENT — Ghent,
- BE-Haine-Saint-Paul-JOLIMONT — Jolimont,
📞 Contact the Study Coordinator
Phone: (010) 703-3740
Email: m.h.g.raaijmakers@erasmusmc.nl
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy — Little Rock, Arkansas
- Azacitidine and Gemtuzumab Ozogamicin in Treating Older Patients With Previously Untreated Acute Myeloid Leukemia — Burbank, California
- A Study to Assess Safety, Tolerability and Preliminary Efficacy of Bexmarilimab in Combination With Standard of Care in Patients With Hematological Malignancies — Duarte, California
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Explore by condition: All Acute Myeloid Leukemia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.