InformationClinical trials have complex eligibility criteria.
Always talk to your clinician about you’re interest in participating in a trial.
Learn why

Optimise reading forHealth ProfessionalsPatients

Closed (no longer recruiting)Last updated: 7 February 2024

VenLDAC: This phase II trial will combine two types of chemotherapy (venetoclax and cytarabine) for the treatment of acute myeloid leukaemia that has not responded or gotten worse with prior therapiesA phase 2 study of venetoclax in combination with low-dose cytarabine in relapsing acute myeloid leukemia

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 patients with Acute Myeloid Leukaemia

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

Trial Acronym

VenLDAC

More information

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Trial sponsor

Alfred Health

Scientific Title

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

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 have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

Participating hospitals

+ Show non-recruiting hospitals

Closed hospitals

InformationTell us if you find this trial availability is not accurate.Report inaccuracy

Get Support

Example

Cancer Connect

You might find it helpful to speak to someone who has 'been there before'. Our Cancer Connect program can provide one-on-one phone support from someone who understands what you're going through and has clinical trials experience.

Learn more

Example

Cancer Council’s cancer nurses

If you need cancer information and practical support for yourself, a carer, family or friend, contact Cancer Council’s experienced cancer nurses on 131120.

Learn more

Example

Information for family, friends and carers

When you are considering a cancer clinical trial, it is a good idea to discuss it with your family, friends or carers.

Learn more

Victorian Cancer Registry Victorian Government

The Victorian Cancer Trials Link is supported by the Victorian Government through the Victorian Cancer Agency.

RAP

Cancer Council Victoria would like to acknowledge the traditional custodians of the land on which we live and work. We would also like to pay respect to the elders past and present and extend that respect to all other Aboriginal people.