Influence of Molecular Abnormalities on Response of VAH vs. VEN+HMA in RR-AML

Nanfang Hospital, Southern Medical University

Status: Completed

Conditions: Cytogenetic Abnormality; Refractory Acute Myeloid Leukemia; Gene Abnormality; Relapsed Acute Myeloid Leukemia

Treatments: Drug: VEN+HMA regimen; Drug: VAH regimen

Study type: Observational

Funder types: Other

Identifiers

NCT05456048

VAH-AML-2022

Details and patient eligibility

About

The aim of this study is to reveal the influence of gene mutations on the treatment response of the regimen of HHT combined with Venetoclax plus AZA versus venetoclax plus HMA in the salvage therapy of RR-AML.

Full description

Venetoclax-based regimens have heen used in the salvage therapy of relapsed/resfractory (RR) acute myeloid leukemia (AML). More and more studies have shown that molecular abnormalities and venetoclax combined regimens significantly impact the response of venetoclax-based therapy. Our exploratory study revealed that venetoclax plus azacytidine combined with homoharringtonine (VAH) had remarkably higher response than venetoclax plus hypomethylating agents (HMA) in RR-AML. Yet the influence of molecular abnormalities on the response of VAH regimen remains unknown.

Enrollment: 231 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. RR-AML
2. Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.

Exclusion criteria

1. Acute promyelocytic leukemia (AML subtype M3)
2. Previous exposure to the treatment of VEN-based regimen
3. Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
4. Respiratory failure (PaO2 ≤60mmHg)
5. Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal [ULN], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
6. Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate < 30 mL/min)
7. ECOG performance status 3, 4 or 5
8. Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
9. Active acute or chronic graft-versus-host disease (GVHD). Active acute GVHD or chronic GVHD is defined as GVHD requiring either at least 1 mg/kg per day of prednisone (or equivalent) or treatment beyond systemic corticosteroids.
10. Patients with pregnancy
11. Uncontrolled active infection
12. Clinically significant coagulation abnormalities

Trial design

231 participants in 2 patient groups

VAH group

Description:

Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML.

Treatment:

Drug: VAH regimen

VEN+HMA group

Description:

Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML.

Treatment:

Drug: VEN+HMA regimen