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Clinical study of Bcl-2 inhibitors combined with azacytidine and chemotherapy in elderly patients with previously untreated acute myeloid leukemia (AML)

Clinical study of Bcl-2 inhibitors combined with azacytidine and chemotherapy in elderly patients with previously untreated acute myeloid leukemia (AML)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045330
Enrollment
Unknown
Registered
2021-04-12
Start date
2021-04-30
Completion date
Unknown
Last updated
2021-11-22

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

Conditions

acute myeloid leukemia

Interventions

Experimental group:Induced remission: Venecola + azacabine
Consolidation therapy (option A or B according to patient's wishes) : Option A (Vinecola + cytarabine + clatribin
Venecola + cytarabine) followed
Plan B (Vinecra + Idabicin + cytarabine
Maintenance period: azacytidine.

Sponsors

The First Hospital of Lanzhou University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Elderly patients with AML diagnosed in accordance with WHO guidelines (2016 edition), aged >= 60 years; 2.Not suitable for standard induction chemotherapy regimens; 3.Eastern Cooperative Oncology Group performance-status score of 0 or 3; 4.The patients and their family members agreed and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs); 2.Infiltration of the central nervous system; 3.Drugs use history affecting CYP3A within 7 days before enrollment; 4.Patients considered by the investigator to be unsuitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Overall survival;Complete remission;Complete remission with incomplete blood count recovery;

Secondary

MeasureTime frame
Time to response;Duration of response;Rates of death;Recurrence rate;

Countries

China

Contacts

Public ContactZhao Long

The First Hospital of Lanzhou University

dragonzhao@126.com+86 18893912796

Outcome results

None listed

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