A phase 2 study of venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukemia

ACTRN 12619000746134

Brief Summary

The purpose of this study is to determine whether Venetoclax (a new drug), when combined with chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells, improves response to treatment.

Intervention/Treatment

• Drug: Ventoclax
• Drug: Cytarabine

Inclusion Criteria

1. Relapsing AML.
2. Received no more than 1 prior line of intensive chemotherapy for AML:
   • Post-remission therapy incl. consolidation, maintenance or HSCT is considered 1 line of therapy.
   • Prior hypomethylating agent is permitted.
3. Age 18 years or older. No upper age limits.
4. ECOG performance status 0-2.
5. Adequate organ function as defined by:
   • Creatinine clearance equal to or greater than 30 ml/min.
   • Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin).
   • Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 3.0 x ULN.
6. WCC <25 x 109/L (hydroxyurea or thioguanine are permitted to meet this criterion).
7. Males with a female partner of childbearing potential must agree to use at least 2 effective contraceptive methods throughout the study and for 30 days following the date of last dosethe amount of medication taken.