Comparison of the efficacy and safety of venetoclax plus azacitidine versus decitabine combined with CAG regimen in the treatment of elderly patients with relapsed or refractory acute myeloid leukemia

A Study on the Efficacy and Safety of Venetoclax Plus Azacitidine Versus DCAG Regimen in Elderly Patients with Relapsed/Refractory Acute Myeloid Leukemia

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2600121428

Enrollment

Unknown

Registered

2026-03-31

Start date

2021-08-09

Completion date

Unknown

Last updated

2026-04-14

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

Conditions

Acute Myeloid Leukemia

Interventions

Venetoclax+AZA group:Venetoclax was administered with dose ramp-up on Days 1–3: 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3, followed by a fixed dose of 400 mg orally on Days 4–28

Azacitidine for injection 75 mg/(m^2·d), D1–7, subcutaneous injection.

D-CAG group:Decitabine 20 mg/(m^2·d), D1–5

Aclarubicin 14 mg/(m^2·d), D3–6

Cytarabine for injection 15 mg/m^2, D6–20

G-CSF 200 µg/(m^2·d), D6–20. During chemotherapy, if WBC > 10 × 10^9/L, G-CSF was withheld for that cycle and resumed after the white blood cell count decreased, without compensating for the days of i

Eligibility

Sex/Gender

All

Age

60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Age >= 60 years (calculated from the date of signed informed consent); 2. Patients with relapsed or refractory acute myeloid leukemia (AML), confirmed by bone marrow morphology and immunology after first-line treatment, excluding M3; 3. ECOG performance status score of 0–3 within 1 week prior to enrollment; 4. Patients voluntarily participate in this study, sign the informed consent form personally or via legally authorized representative, with good compliance and willingness to comply with follow-up; 5. No severe organic diseases in other organs.

Exclusion criteria

Exclusion criteria: 1. Patients with contraindications to chemotherapy, poor compliance, severe mental disorders, or those who are lost to follow-up; 2. Patients with severe organic lesions in the heart, liver, and kidney functions; 3. Patients with other severe diseases of the hematological system (other than leukemia) or severe immune system disorders.

Design outcomes

Primary

Measure	Time frame
complete remission rate(CR);objective response rate (ORR);	—

Secondary

Measure	Time frame
overall survival (OS);progression-free survival (PFS);	—

Countries

China

Contacts

Public ContactLiu Zhanyun

Department of Hematology, Shanghai Jing’an District Beizhan Hospital,Shanghai

lzy7706@126.com+86 137 0179 0426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 17, 2026