Influence of Molecular Abnormalities on Treatment Response of the Regimen of Venetoclax Plus Azacytidine Combined With Homoharringtonine Versus Venetoclax Plus Hypomethylating Agents (HMA) in Relapsed/Refractory Acute Myeloid Leukemia
Overview
- Phase
- Not Applicable
- Intervention
- VAH regimen
- Conditions
- Relapsed Acute Myeloid Leukemia
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 231
- Locations
- 1
- Primary Endpoint
- CR/CRi
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Qifa Liu
Professor
Nanfang Hospital, Southern Medical University
Eligibility Criteria
Inclusion Criteria
- •Patients must have been treated for at least one cycle of VEN-based regimen and finished outcome assessment.
Exclusion Criteria
- •Acute promyelocytic leukemia (AML subtype M3)
- •Previous exposure to the treatment of VEN-based regimen
- •Cardiac dysfunction (particularly congestive heart failure, unstable coronary artery disease and serious cardiac ventricular arrhythmias requiring antiarrhythmic therapy)
- •Respiratory failure (PaO2 ≤60mmHg)
- •Hepatic abnormalities (total bilirubin ≥2 times the upper limit of normal \[ULN\], alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 times the ULN)
- •Renal dysfunction (creatinine ≥2 times the ULN or creatinine clearance rate \< 30 mL/min)
- •ECOG performance status 3, 4 or 5
- •Substantial history of neurological, psychiatric, endocrine, metabolic, immunological, or any other medical condition not suitable for the trial (investigators' decision)
- •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.
- •Patients with pregnancy
Arms & Interventions
VAH group
Patients assigned to this group received one to two cycles of VAH regimen as salvage therapy of RR-AML.
Intervention: VAH regimen
VEN+HMA group
Patients assigned to this group received one to two cycles of venetoclax plus HMA regimen as salvage therapy of RR-AML.
Intervention: VEN+HMA regimen
Outcomes
Primary Outcomes
CR/CRi
Time Frame: At the end of Cycle 2 (each cycle is 28 days)
Complete remission and CR with incomplete count recovery
Secondary Outcomes
- MRD negative(At the end of Cycle 2 (each cycle is 28 days))
- Overall response(At the end of Cycle 2 (each cycle is 28 days))
- Overall survival(2 years)
- Event-free survival(2 years)