Actively Recruiting
BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
Led by Chen Suning · Updated on 2024-12-24
135
Participants Needed
1
Research Sites
131 weeks
Total Duration
On this page
Sponsors
C
Chen Suning
Lead Sponsor
B
BioNova Pharmaceuticals (Shanghai) LTD.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
CONDITIONS
Official Title
BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have been fully informed about the study and voluntarily signed the informed consent form
- Diagnosed with newly diagnosed primary AML or relapsed/refractory AML with specific mutations (KMT2A rearrangement, NPM1 mutation, or NUP98 rearrangement)
- Peripheral blood leukocyte count 3 25 x 10^9/L (for groups B and C; hydroxyurea allowed to control count)
- Aged 18 years or older
- ECOG performance status 0, 1, or 2 (groups A and B); 0, 1, 2, or 3 (group C)
- For group B, unfit for intensive chemotherapy defined by age 3 75 years or age 18-74 with specified co-morbidities including cardiac, lung, kidney, or liver function limits
- For group C, prior failure with menin inhibitor treatment
- Adequate liver, kidney, and heart function as defined by specified laboratory criteria
- Negative tests for active deep vein thrombosis or coagulation disorders if D-dimer >5x upper limit
- Expected survival of more than 12 weeks
- Willingness to attend study visits as required
- Use of effective contraception during the study for patients of childbearing potential
You will not qualify if you...
- Active central nervous system leukemia
- Clinically significant liver disease including viral hepatitis or cirrhosis (positive viral tests require further negative confirmatory tests)
- Known HIV infection
- Pregnant or lactating females
- Significant cardiac conditions including hereditary long QT syndrome, recent heart attack, unstable angina, recent coronary artery bypass grafting, or heart failure NYHA grade 2 or higher
- History of other cancers within 5 years except certain treated skin or in situ carcinomas
- Prior anti-leukemia therapy (except limited use of hydroxyurea or specific exceptions for groups A and B)
- Recent chemotherapy, radiotherapy, or immunotherapy within specified timeframes for group C
- Prior treatment with menin inhibitors for groups A and B
- Persistent significant non-blood toxicities
- Positive tuberculosis screening if pulmonary nodules detected
- Uncontrolled active infections requiring hospitalization or intravenous antibiotics
- Conditions limiting oral drug intake or absorption
- Severe allergy to menin inhibitors or BN104 components
- Poor compliance potential or other medical conditions judged unsuitable by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China, 215000
Actively Recruiting
Research Team
S
Suning Chen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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