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A single-center, single-arm observational study of venetoclax maintenance therapy in patients with acute myeloid leukemia ineligible for hematopoietic stem cell transplantation

A single-center, single-arm observational study of venetoclax maintenance therapy in patients with acute myeloid leukemia ineligible for hematopoietic stem cell transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400092661
Enrollment
Unknown
Registered
2024-11-21
Start date
2024-11-30
Completion date
Unknown
Last updated
2024-12-02

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:Low-dose monotherapy of venetoclax

Sponsors

Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to No maximum

Inclusion criteria

Inclusion criteria: A. Patients with acute myeloid leukemia (other than acute promyelocytic leukemia) confirmed by bone marrow examination, who had completed induction and consolidation chemotherapy, remained in residual disease-negative complete remission (CRMRD-) as assessed before enrollment, and were ineligible or unwilling to undergo hematopoietic stem cell transplantation. B. over 14 years old, regardless of gender or race; C. Physical status: ECOG score 0-3; D. Cardiac function: left ventricular ejection fraction = 40%; E. Expected survival time > 12 weeks; F. Serum creatinine (Cr) =1.5×ULN (upper limit of normal), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5×ULN, total bilirubin =1.5×ULN; G. The patient is self-aware and able to sign informed consent; The guardian of the child patient agreed to sign the informed consent. F. Lactating women were required to discontinue breastfeeding to participate in the study

Exclusion criteria

Exclusion criteria: A. Except for patients with non-remission of the primary disease or positive residual disease; B. Pregnant women, women who do not agree to stop breastfeeding during lactation; C. active HBV or HCV infection; D. People living with HIV;

Design outcomes

Primary

MeasureTime frame
leukemia-free survival;

Secondary

MeasureTime frame
Overall?Survival;Duration of Overall Response;The incidence of adverse effects;

Countries

China

Contacts

Public ContactJuan Tong

Department of Hematology of Anhui Provincial Hospital, the First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

tongj5200@163.com+86 139 5511 4442

Outcome results

None listed

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