Clinical Trials List
Protocol Number75276617AML3001
Active
2025-02-28 - 2029-08-15
Phase III
Recruiting4
A phase 3, randomized, double-blind, placebo-controlled trial of Bleximenib, Venetoclax, and Azacitidine in newly diagnosed acute myeloid leukemia patients with KMT2A gene recombination or NPM1 gene mutation who were ineligible for high-intensity chemotherapy.
-
Trial Applicant
Johnson & Johnson
-
Sponsor
Johnson & Johnson Inc.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/08/17
Investigators and Locations
Co-Principal Investigator
- 林正耀 Division of Hematology & Oncology
- 林建良 Division of Hematology & Oncology
- 高婉真 Division of Hematology & Oncology
- 曹朝榮 Division of Hematology & Oncology
- Shang-Wen Chen Division of Hematology & Oncology
- 陳冠宇 Division of Hematology & Oncology
- 陳彥勳 Division of Hematology & Oncology
- 陳昭勳 Division of Hematology & Oncology
- 黃文聰 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 田豐銘 Division of General Internal Medicine
- 李思慧 Division of General Internal Medicine
- Wen-Chien Chou Division of General Internal Medicine
- Chien-Chin Lin Division of General Internal Medicine
- MING YAO Division of General Internal Medicine
- YAO CHI-YUAN Division of General Internal Medicine
- - - Division of General Internal Medicine
- Huai-Hsuan Huang Division of General Internal Medicine
- CHENG-HONG TSAI Division of General Internal Medicine
- Chieh-Lung Cheng Division of General Internal Medicine
- 袁章祖 Division of Others
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Principal Investigator
Ming-Chung Kao
Co-Principal Investigator
- 王元欽 Division of Hematology & Oncology
- Tung-Liang Lin Division of Hematology & Oncology
- HSUAN JEN SHIH Division of Hematology & Oncology
- 洪玉馨 Division of Hematology & Oncology
- Hsiao-Wen Kao Division of Hematology & Oncology
- 張 鴻 Division of Hematology & Oncology
- 蘇羿囷 Division of Hematology & Oncology
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Acute myeloid leukemia
Objectives
The aim of this study was to evaluate the efficacy of Bleximenib and Venetoclax (VEN) + Azacitidine (AZA) compared with placebo and VEN + AZA in newly diagnosed acute myeloid leukemia (AML) patients with NPM1 or KMT2A gene mutations.
Test Drug
Azacitidine
Bleximenib
Venetoclax
Bleximenib
Venetoclax
Active Ingredient
Azacitidine
Bleximenib
Venetoclax
Bleximenib
Venetoclax
Dosage Form
Frozen Crystal Injection
Tablets
Film-Coated Tablets
Tablets
Film-Coated Tablets
Dosage
N/A
N/A
N/A
N/A
N/A
Endpoints
- Percentage of participants who achieved complete remission (CR).
- Overall survival (OS).
- Overall survival (OS).
Inclution Criteria
Must be 18 years of age or older at the time of signing the informed consent form.
Must have untreated KMT2A recombinant (KMT2Ar) or NPM1 gene mutation (NPM1m) acute myeloid leukemia (AML) meeting the 2022 International Consensus Classification (ICC) criteria, with a myeloblastic cytology ≥ 10%.
Must be unsuitable for high-intensity chemotherapy based on the following criteria:
• ≥ 75 years of age and deemed unsuitable by a physician, with an East Coast Cancer Clinical Research Consortium (ECOG) performance status score of 0-2
• ≥ 18 to < 75 years of age and have ≥ 1 of the following comorbidities:
- ECOG performance status score of 2
- Severe heart disease
- Severe lung disease
- Kidney impairment
- Moderate liver impairment
- Comorbidities deemed by the trial administrator to make the participant unsuitable for high-intensity chemotherapy, which must have been recorded prior to enrollment and approved by the trial commissioner.
Participants must have adequate liver and kidney function.
Female participants must agree not to become pregnant, breastfeed, or plan to become pregnant during the trial and for six months after the last dose of treatment, and must use the contraceptive methods specified in the trial protocol.
Male participants must agree to use the contraceptive methods specified in the trial protocol during the trial and for six months after the last dose of treatment.
Participants must sign a participant consent form indicating that they understand the purpose and procedures of the trial and are willing to participate.
Must have untreated KMT2A recombinant (KMT2Ar) or NPM1 gene mutation (NPM1m) acute myeloid leukemia (AML) meeting the 2022 International Consensus Classification (ICC) criteria, with a myeloblastic cytology ≥ 10%.
Must be unsuitable for high-intensity chemotherapy based on the following criteria:
• ≥ 75 years of age and deemed unsuitable by a physician, with an East Coast Cancer Clinical Research Consortium (ECOG) performance status score of 0-2
• ≥ 18 to < 75 years of age and have ≥ 1 of the following comorbidities:
- ECOG performance status score of 2
- Severe heart disease
- Severe lung disease
- Kidney impairment
- Moderate liver impairment
- Comorbidities deemed by the trial administrator to make the participant unsuitable for high-intensity chemotherapy, which must have been recorded prior to enrollment and approved by the trial commissioner.
Participants must have adequate liver and kidney function.
Female participants must agree not to become pregnant, breastfeed, or plan to become pregnant during the trial and for six months after the last dose of treatment, and must use the contraceptive methods specified in the trial protocol.
Male participants must agree to use the contraceptive methods specified in the trial protocol during the trial and for six months after the last dose of treatment.
Participants must sign a participant consent form indicating that they understand the purpose and procedures of the trial and are willing to participate.
Exclusion Criteria
**Diagnosis of Acute Premyeloid Leukemia (APL)**
**Active Leukemia Known to Involve the Central Nervous System (CNS)**
**Solid Organ Transplant Recipients**
**Any Cardiac Disorders Within 6 Months Prior to Randomization**, such as Heart Attack, Uncontrolled/Unstable Chest Pain, Congestive Heart Failure, Uncontrolled or Symptomatic Arrhythmia, Cerebral Vascular Obstruction, or Transient Ischemic Attack (Tissue Oxygen Deprivation).
**Active Infectious Hepatitis**
**Received a Live Attenuated Vaccine Within 4 Weeks Prior to Randomization**
**Known Hypersensitivity, Allergic Reaction, or Intolerance to the Excipients of Bleximenib**
**Active Leukemia Known to Involve the Central Nervous System (CNS)**
**Solid Organ Transplant Recipients**
**Any Cardiac Disorders Within 6 Months Prior to Randomization**, such as Heart Attack, Uncontrolled/Unstable Chest Pain, Congestive Heart Failure, Uncontrolled or Symptomatic Arrhythmia, Cerebral Vascular Obstruction, or Transient Ischemic Attack (Tissue Oxygen Deprivation).
**Active Infectious Hepatitis**
**Received a Live Attenuated Vaccine Within 4 Weeks Prior to Randomization**
**Known Hypersensitivity, Allergic Reaction, or Intolerance to the Excipients of Bleximenib**
The Estimated Number of Participants
-
Taiwan
20 participants
-
Global
600 participants
