CompletedNot Applicable

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

China231 participantsStarted 2018-12-03

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. RR-AML
✓. 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)

What they're measuring

CR/CRi

Timeframe: At the end of Cycle 2 (each cycle is 28 days)

Trial details

NCT IDNCT05456048

SponsorNanfang Hospital, Southern Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-05-31

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