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A prospective, single-arm, open label, multi-center exploratory clinical study of the combination of alcarubicin, G-CSF and cytarabine with venetoclax (CAGV) in the treatment of previously untreated patients with acute myeloid leukemia (AML) who are elderly or not suitable for conventional chemotherapy.

A prospective, single-arm, open label, multi-center exploratory clinical study of the combination of alcarubicin, G-CSF and cytarabine with venetoclax (CAGV) in the treatment of previously untreated patients with acute myeloid leukemia (AML) who are elderly or not suitable for conventional chemotherapy.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090050
Enrollment
Unknown
Registered
2024-09-23
Start date
2024-06-11
Completion date
Unknown
Last updated
2024-09-30

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

Conditions

acute myeloid leukemia

Interventions

trial group:CAGV regimen

Sponsors

The First Affiliated Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Age over 60 years old, or no more than 60 years old but assessed by the researcher as unsuitable for conventional chemotherapy. (2) Diagnosed as AML according to the WHO 2016 classification criteria for hematopoietic and lymphoid tissue tumors. (3) ECOG PS <= 2. (4) Having sufficient liver and kidney function, defined as follows: liver function: serum total bilirubin (TBIL) < 2 x upper limit of normal value (ULN); Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) are less than 3 × ULN. Renal function: Serum creatinine (Cr) < 2 x ULN. (5) Voluntary participation, willingness to provide the above treatment data, and signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients who are allergic to the medication used in this study (2) Patients with unstable or active cardiovascular diseases, or with active infections that have not been effectively controlled by medication within one week prior to the first treatment, or with HBV and HCV active infections (3) Patients who have received anti-leukemia treatment before the study, excluding those who have previously been diagnosed with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) and received demethylation therapy (decitabine or azacitidine) (4) Diagnosed as acute promyelocytic leukemia, or patients with central nervous system symptoms who are suspected of central nervous system leukemia or other central diseases (5) Combined with other malignant tumors that still require treatment (6) Serious mental or neurological disorders that affect informed consent and/or expression or observation of adverse reactions (7) Pregnant, lactating women, and childbearing age patients who are unwilling to take contraceptive measures (8) Patients who cannot be followed up (9) The researcher determined that they are not suitable to participate in this study.

Design outcomes

Primary

MeasureTime frame
overall response rate (ORR);

Secondary

MeasureTime frame
Duration of response (DOR);12-month survival rate;Adverse events (AEs) of the treatment protocol;

Countries

China

Contacts

Public ContactJingsong He; Xiujin Ye

The First Affiliated Hospital, Zhejiang University School of Medicine

hejingsong@zju.edu.cn+86 136 0054 7247

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026