Clinical study protocol of Venetoclax combined with Azacitidine and Harringtonine in the treatment of secondary Acute Myeloid Leukemia

A clinical study to evaluate the efficacy and safety of Venetoclax in combination with Azacitidine and Harringtonine in patients with sAML

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200064197

Enrollment

Unknown

Registered

2022-09-29

Start date

2022-09-30

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

sAML

Interventions

Experimental group: Venetoclax combined with Azacitidine and Harringtonine

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients with acute myeloid leukemia (AML) newly diagnosed by bone marrow morphology and immunotyping (meeting WHO 2016 diagnostic criteria) ; 2. Treatment-related AML patients (tAML); 3. AML patients with previous history of MDS or CMML; 4. AML patients with cytogenetic abnormalities related to myelodysplasia; 5. Aged 18-80 years (not including 80); 6. ECOG performance status score = 50%; 9. Informed consent was obtained from the patient or legal representative.

Exclusion criteria

Exclusion criteria: 1. AML with central nervous system (CNS) infiltration; 2. Acute promyelocytic leukemia confirmed by bone marrow morphology or immunophenotyping; 3. Have received Veneclare treatment in the past; 4. Those who are known to be allergic to any drugs or other ingredients in the program; 5. Currently suffering from active autoimmune disease or a history of autoimmune disease potentially involving the CNS; 6. Known human immunodeficiency virus (HIV) infection; 7. Known history of active hepatitis B or C (HBV, HCV) infection; 8. Pregnant women and women who are trying to conceive; 9. Suffering from severe and/or uncontrolled mental illness; 10. Any life-threatening disease, health condition, or organ system dysfunction that the investigator believes may compromise the safety of the subject, or create an undue risk to the research results; 11. Received major surgery within 4 weeks before randomization; 12. Participate in other clinical investigators at the same time one month before enrollment.

Design outcomes

Primary

Measure	Time frame
Compound complete response rate;	—

Secondary

Measure	Time frame
CR+CRi Duration (DoR);Overall response rate (ORR);Small Residual Lesion (MRD);Event-free survival (EFS);Overall survival (OS);Allogeneic hematopoietic stem cell transplantation;	—

Countries

China

Contacts

Public ContactWenyi Shen

Jiangsu Provincial Hospital

bangbangswy@163.com+86 13951614203

Outcome results

None listed

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