Idarubicin plus azacitidine and venetoclax as first-line treatment for old-fit adults with acute myeloid leukemia: a single-centre, single-arm, phase 2 trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070190

Enrollment

Unknown

Registered

2023-04-04

Start date

2023-04-05

Completion date

Unknown

Last updated

2023-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute myeloid leukemia

Interventions

Study group:IDA+AZA+VEN

Eligibility

Sex/Gender

All

Age

60 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. AML diagnosed by both morphology and immunology; 2. Aged >= 60 years; 3. At least 12 weeks of life expectancy; 4. Performance status: access as FIT status though "The ELDERLY AML Assessment Scale" (Department of Hematology, Ruijin Hospital); 5. Liver and renal function: serum bilirubin = 50%, NYHA I/II); 7. Signed written informed consent; 8. No Central Nervous System Symptoms; 9. Obtain an informed consent signed by the subject or family, and the subject or family member understands the characteristics of the disease and voluntarily joins this study protocol for treatment and follow-up; 10. Subjects agree not to participate in another interventional study during treatment.

Exclusion criteria

Exclusion criteria: 1. Secondary AML; mixed-lineage leukemia; AML with CNS-infiltration or extramedullary disease; 2. Previously treated patients; 3. Allergy or contraindication to any medication in the regimen; 4. Abnormal liver and kidney function, exceeding the entry criteria; 5. Heart disease, including echocardiographic EF 2),prolonged QTc > 470ms; 6. Patients with pulmonary complications, including pleural effusion, pulmonary edema (CTCAE grade > 2); 7. Patients with a "currently active" second malignancy; 8. Patients with "currently active" tuberculosis. Patients with HAV, HBV, HCV or HIV; 9. Patients with other hematological disease (including abnormal coagulation which is unrelated to leukemia); 10. Patients who can't understand or obey the protocol; 11. Patients who are participating in other clinical trial; 12. Other circumstance that obstructs the clinical trial.

Design outcomes

Primary

Measure	Time frame
Complete Remission Rate;Duration of remession;	—

Secondary

Measure	Time frame
Incidence rate and severity of adverse events;MRD-negtive CR rate;	—

Countries

China

Contacts

Public ContactYang Shen

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai, China

yang_shen@sjtu.edu.cn+86 21 6437 0045

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 8, 2026