OncoMatch/Clinical Trials/NCT05904106
Venetoclax Plus Azacitidine Versus Intensive Chemotherapy for Fit Patients With Newly Diagnosed NPM1 Mutated AML
Is NCT05904106 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including Venetoclax plus Azacitidine and standard of care chemotherapy plus gemtuzumab ozogamicin for acute myeloid leukemia.
Treatment: Venetoclax plus Azacitidine · standard of care chemotherapy plus gemtuzumab ozogamicin — This phase II clinical trial evaluates the efficacy and tolerability of the non-intensive treatment with venetoclax and the hypomethylating agent azacitidine as compared to the standard of care chemotherapy plus gemtuzumab ozogamicin in newly diagnosed NPM1 mutated AML patients fit for intensive chemotherapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Other
Cancer type
Acute Myeloid Leukemia
Biomarker criteria
Required: CD33 positive
Required: NPM1 mutation
Excluded: FLT3 activating mutation
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Demographics
Prior therapy
Cannot have received: hypomethylating agent
Previous treatment with HMA
Cannot have received: (venetoclax)
Previous treatment with venetoclax
Cannot have received:
Exception: hydroxyurea permitted
Previous treatment for AML except hydroxyurea
Cannot have received: anthracycline
Cumulative previous exposure to anthracyclines of > 200 mg/m^2 doxorubicin equivalents
Lab requirements
Blood counts
WBC < 25 x 10^9/L (<25,000/µL), prior hydroxyurea is permitted to meet this criterion
Kidney function
serum creatinine ≤ 1.5x ULN OR creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min
Liver function
ALAT/ASAT/Bilirubin ≤ 2.5 x ULN unless considered due to leukemic organ involvement. Subjects with Gilbert's Syndrome may have a bilirubin > 2.5 × ULN per discussion between the investigator and Coordinating investigator.
Cardiac function
NYHA Class < 2; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); no serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
Adequate hepatic function: ALAT/ASAT/Bilirubin ≤ 2.5 x ULN unless considered due to leukemic organ involvement. Adequate renal function assessed by serum creatinine ≤ 1.5x ULN OR creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min. WBC < 25 x 10^9/L (<25,000/µL), prior hydroxyurea is permitted to meet this criterion. Cardiovascular disability status of New York Heart Association (NYHA) Class ≥ 2; unstable coronary artery disease (MI more than 6 months prior to study entry is permitted); serious cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT05904106 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CD33?
Yes, CD33 positive is a required biomarker for enrollment.
Does this trial require NPM1?
Yes, NPM1 mutation is a required biomarker for enrollment.
Are patients with FLT3 alterations eligible?
No. FLT3 activating mutation is an exclusion criterion.
Is there an age limit?
Yes. Patients must be 70 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages