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A cohort study of azacitidine combined with different dosages of venetoclax in the treatment of elderly patients with AML unsuitable for chemotherapy

A cohort study of azacitidine combined with different dosages of venetoclax in the treatment of elderly patients with AML unsuitable for chemotherapy

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084836
Enrollment
Unknown
Registered
2024-05-27
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

AML

Interventions

AZA plus Ven:None
AZA plus low dose Ven:None

Sponsors

Beijing Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Age = 65 years old; (2) Complies with AML (non APL) according to WHO diagnostic criteria; (3) Previously untreated; (4) No uncontrolled current infections (new infections, broad-spectrum antibiotics with body temperature still above 38 ? after 72 hours, excluding other non infectious factors); (5) IACA assessed as unsuitable or fragile.

Exclusion criteria

Exclusion criteria: (1) Patients with central nervous system involvement; (2) Patients with life-threatening or treatment-influencing complications who merge; (3) Patients with severe allergies to azacytidine or vinpoclavone; (4) Patients with clinical symptoms of brain dysfunction or severe mental illness who cannot understand or follow the protocol; (5) Patients with other malignant tumors that require treatment; (6) According to the judgment of the researchers, the patient has other unsuitable enrollment situations.

Design outcomes

Primary

MeasureTime frame
Composite complete remission rate;

Secondary

MeasureTime frame
Overall response rate;Complete remission rate;Relapse Rate;Overall survival;Relapse free survival;Event free survival;Minimal residual disease;Adverse event;Transfusion dependence;

Countries

China

Contacts

Public ContactRu Feng

Beijing Hospital

frbld@sina.com+86 131 6182 8075

Outcome results

None listed

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