Six Acute Myeloid Leukemia Clinical Trials Currently Recruiting

It is essential for clinicians to remain informed about emerging clinical trial opportunities and resulting data that may inform therapeutic strategies, affect clinical guidelines, expand treatment options, and ultimately improve patient quality of life.

Today's rundown focuses on acute myeloid leukemia clinical trials that are currently active in the United States. All trials featured today are currently recruiting, as of September 2, 2026. Trials are arranged in order of their start date.

Quick View Table of Acute Myeloid Leukemia Clinical Trials

Featured Phase 3 Clinical Trials

A Study to Assess Adverse Events and Change in Disease Activity When Intravenous (IV) Pivekimab Sunirine is Given in Combination With Oral Venetoclax and IV or Subcutaneous Azacitidine in Adult Participants With Acute Myeloid Leukemia

• Sponsor: AbbVie
• Goal: This study will assess the adverse events and changes in the disease activity when Pivekimab Sunirine (PVEK) is given in combination with Venetoclax (VEN) and Azacitidene (AZA) in adult participants with AML ineligible to receive intensive chemotherapy.
• Interventions: Pivekimab sunirine, venetoclax, azacitidine, matching placebo for PVEK
• Primary Outcome Measures: Phase 2: Complete remission (CR); Phase 3: Complete remission (CR); Phase 3: Overall Survival (OS); Number of Participants with Adverse Events (AEs).
  Time Frames: Up to approximately 71 months; Up to approximately 71 months; Up to approximately 71 months; Up to approximately 71 months.
• Study Details
• Source

Bleximenib in Combination With Standard Induction and Consolidation Therapy Followed by Maintenance for Treatment of Patients With Acute Myeloid Leukemia (AML)

• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
• Goal: 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.
• Interventions: Bleximenib, cytarabine, daunorubicin or idarubicin, placebo
  Primary Outcome Measure: Event-Free Survival (EFS) in adult patients with newly diagnosed NPM1m or KMT2Ar AML eligible for intensive chemotherapy.
• Time Frame: Up to four years and five months.
• Study Details
• Source

Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation (REVEAL-ND NPM1)

• Sponsor: Syndax Pharmaceuticals
• Goal: The purpose of this study is to assess if adding revumenib to standard chemotherapy improves outcomes in participants with AML with certain genetic mutations compared to chemotherapy alone. The study will also assess the safety of adding revumenib to chemotherapy.
• Interventions: Revumenib, placebo, intensive chemotherapy regimen
• Primary Outcome Measures: Event free survival; Measurable residual disease complete remission rate.
• Time Frames: Up to two years; Up to two years.
• Study Details
• Source

Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML

• Sponsor: Kura Oncology
• Goal: This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML.
• Interventions: Ziftomenib, placebo, venetoclax, azacitidine, daunorubican, cytarabine
• Primary Outcome Measures: Nonintensive Therapy Study: (Primary Endpoint for all countries): Overall survival (OS); Nonintensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR); Intensive Therapy Study: (Primary Endpoint for all countries): Event-free survival (EFS); Intensive Therapy Study: (Dual Primary Endpoint for US & US reference countries only): Complete remission (CR) with bone marrow (BM) measurable residual disease (MRD) negativity in NPM1-m patients.
• Time Frames: Defined as the time from randomization to date of death from any cause, assessed up to 36 months after last patient inclusion; Assessed up to 36 months after last patient inclusion; Defined as the time from randomization to treatment failure, hematologic relapse following CR, or death from any cause, whichever comes first, assessed up to 36 months after last patient inclusion; Assessed up to 36 months after last patient inclusion.
• Study Details
• Source

A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) (cAMeLot-2)

• Sponsor: Janssen Research and Development
• Goal: The purpose of this study is to assess how bleximenib and Venetoclax (VEN)+ Azacitidine (AZA) works as compared to placebo and VEN+AZA alone for the treatment of participants with newly diagnosed Acute Myeloid Leukemia (AML) with a mutation in the NPM1 or KMT2A gene.
• Interventions: Bleximenib, venetoclax, azacitidine, placebo
• Primary Outcome Measures: Percentage of participants who achieve complete remission; overall survival.
• Time Frames: Up to four years and one month; Up to four years and one month.
• Study Details
• Source

Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML

• Sponsor: Stichting Hemato-Oncologie voor Volwassenen Nederland
• Goal: The current study investigates whether adding revumenib to the combination therapy improves the prognosis for AML patients with a mutation in the NPM1 or KMT2A gene.
• Interventions: Revumenib, placebo.
• Primary Outcome Measures: Overall survival (OS) in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy; Rate of CR in adult patients with newly diagnosed NPM1-mutated AML ineligible for intensive chemotherapy.
• Time Frames: 58 months after last patient inclusion; 58 months after the first randomized NPM1-mutated AML patient.
• Study Details
• Source

Related Clinical Guidance:

• Treating Newly Diagnosed Acute Myeloid Leukemia in Older Adults
  • American Society of Hematology
  • November 2025

• Antifungal Prophylaxis in Adult Patients with Acute Myeloid Leukaemia Treated with Novel Targeted Therapies
  • European Hematology Association
  • May 2022

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