Skip to content

H(E)AG Regimen Combined with Venetoclax and Azacitidine for the Treatment of Relapsed/Refractory Acute Myeloid Leukemia: A Multicenter, Retrospective Cohort Study

H(E)AG Regimen Combined with Venetoclax and Azacitidine for the Treatment of Relapsed/Refractory AML: A Multicenter, Retrospective Cohort Clinical Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500097988
Enrollment
Unknown
Registered
2025-02-28
Start date
2025-03-05
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

Acute Myeloid Leukemia

Interventions

Group 1: Patients treated with H(E)AG + Venetoclax + Azacitidine:None
Group 2: Patients treated with H(E)AG alone:None

Sponsors

The second affiliated hospital of the army medical university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: (1) Clinical diagnosis of relapsed and refractory AML Definition of relapsed/refractory: 1) Recurrent disease: Leukemia cells or blasts in the bone marrow >=5% in the peripheral blood after complete remission (CR) of AML (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or leukemia cell infiltration outside the medulla. 2) MRD recurrence: from MRD negative to MRD positive; 3) Refractory disease: naïve cases that have failed to respond to two courses of treatment with standard regimens; After CR after consolidation and intensive therapy, recurrence within 12 months; Those who relapse after 12 months and do not respond to conventional chemotherapy; Those with two or more recurrences; Extramedullary leukemia persistent. 4) Patients with newly diagnosed AML do not respond within one course of treatment (2) The date of relapse or refractory is defined as the date of sampling on the first bone marrow cytogenetics or molecular report. (3) Age>=18 years, <=70 years; (4) Patients admitted to the hospital for treatment; (5) The patient agrees to participate in this study and signs the informed consent form; (6) Detailed diagnosis and treatment and follow-up data can be obtained

Exclusion criteria

Exclusion criteria: (1) Acute promyelocytic leukemia; (2) Patients with other untreated malignancies.

Design outcomes

Primary

MeasureTime frame
The modified composite complete remission (mCRc) rate;

Secondary

MeasureTime frame
Overall Survival(OS);Progression-Free Survival (PFS);Duration of Response (DOR);Adverse Events (Safety);Overall Response Rate (ORR);

Countries

China

Contacts

Public ContactWen Qin

The second affiliated hospital of the army medical university

qiqi105@sina.com+86 136 5833 7056

Outcome results

None listed

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