Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
All eligible patients will receive 600mg of oral venetoclax once daily (QD) in a 28-day cycle. This will be followed, on Days 1-10 of every cycle, by a subcutaneous injection of cytarabine (20mg/m2) once daily. Patients will remain on treatment for up to 24 cycles unless discontinuation criteria is met.
Conditions
This trial is treating people with Acute Myeloid Leukaemia
Eligibility
Inclusion
1. Relapsing AML
2. Received no more than 1 prior line of intensive chemotherapy for AML
a. Post-remission therapy incl. consolidation, maintenance or HSCT is considered 1 line of therapy
b. 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:
a. Creatinine clearance equal to or greater than 30 ml/min
b. Bilirubin less than or equal to 1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
c. 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 dose
Exclusion
1. Acute promyelocytic leukemia
2. Prior and concomitant therapy
a. Anticancer therapies including chemotherapy, radiotherapy, or other investigational therapy, including targeted small molecule agents: exclude 5 half-lives prior to first dose and throughout venetoclax administration
b. Biologic agents (e.g. monoclonal antibodies) for anti-neoplastic intent: exclude 30 days prior to first dose and throughout venetoclax administration
3. Prior exposure to Venetoclax or other BCL-2 inhibitors
4. Known contraindication of or allergy to allopurinol, xanthine oxidase inhibitors and rasburicase
5. History of malignancy with the exception of:
a. Adequately treated in situ carcinoma of the cervix uteri
b. Adequately treated non-melanoma skin cancer
c. Localized prostate cancer with no requirement for therapy
d. Prior cancer not requiring active therapy and with an expected survival greater than 2 years
6. Subject is known to be positive for HIV (HIV testing is not required)
7. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
b. Chronic hepatitis B virus (HBV) or hepatitis C (HCV) requiring treatment. Note: subjects with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from intravenous immunoglobulins (IVIg) may participate
8. Treatment with any of the following within 7 days prior to the first dose of study drug:
a. Steroid therapy for anti-neoplastic intent
b. Moderate or strong CYP3A inhibitors
c. Moderate or strong CYP3A inducers
9. Administration or consumption of any of the following within 3 days prior to the first dose of study drug:
a. Grapefruit or grapefruit products
b. Seville oranges (including marmalade containing Seville oranges)
c. Star fruit
10. Significant medical, psychiatric, or any other condition that in the opinion of the investigator would adversely affect subject’s participation in this study or interpretation of study results
Inclusion
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
- You are currently being treated on a clinical trial.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ANZCTR *. View further details about this trial on the registry via the links below:
Trial sponsor
Alfred Health
Scientific Title
A phase 2 study of venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukemia
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