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Venetoclax combined with half-dose CMG regimen (cytarabine, mitoxantrone liposomes, and granulocyte colony-stimulating factor) for the treatment of newly diagnosed patients who are intolerant to intensive chemotherapy Single-center, exploratory clinical study on acute myeloid leukemia

Venetoclax combined with half-dose CMG regimen (cytarabine, mitoxantrone liposomes, and granulocyte colony-stimulating factor) for the treatment of newly diagnosed patients who are intolerant to intensive chemotherapy Single-center, exploratory clinical study on acute myeloid leukemia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105011
Enrollment
Unknown
Registered
2025-06-26
Start date
2024-04-14
Completion date
Unknown
Last updated
2025-06-30

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

Conditions

Acute myeloid leukemia

Interventions

Therapy group:Undergo induction therapy with the VCMG regimen

Sponsors

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) The patient or legal guardian voluntarily participates and signs the informed consent form; (2) The patient's life expectancy is at least 12 weeks; (3) Patients are not suitable for intensive chemotherapy, defined as follows: Age >= 75 years, or age 18-74 years, and meeting all of the following criteria: a) Eastern Cooperative Oncology Group (ECOG) score of 2 or 3 b) History of chronic congestive heart failure, chronic stable angina, or left ventricular ejection fraction (LVEF) =50% c) Creatinine clearance rate >=30ml/min and 1.5 and = 75 years with ECOG score of 0-2, or age 18-74 years with ECOG score of 0-3; (5) Creatinine clearance rate >= 30 ml/min; (6) Alanine aminotransferase (ALT) <= 3.0 times the upper limit of normal (ULN), aspartate aminotransferase (AST) <= 3.0 times the upper limit of normal (ULN), total bilirubin <= 3.0 times the upper limit of normal (ULN) (excluding liver infiltration in leukemia).

Exclusion criteria

Exclusion criteria: (1) Patients with acute promyelocytic leukemia; (2) AML transformed from myeloproliferative neoplasms; (3) Patients with central nervous system leukemia; (4) Women who are pregnant or breastfeeding; (6) HIV-infected patients; (7) Patients with uncontrollable active infections; (8) Patients with active hepatitis B or C; (9) Suffering from mental illness; (10) The patient has drug abuse/addiction; (11) According to the researcher's judgment, the patient has other conditions that make them unsuitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Remission rate;

Secondary

MeasureTime frame
Safety;Progression-free survival rate;Overall survival rate;

Countries

China

Contacts

Public ContactZhichao Li

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

li_zhichao@126.com+86 130 5227 5415

Outcome results

None listed

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