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CAVEAT : A phase Ib clinical evaluation of Venetoclax in combination with chemotherapy in older patients with Acute Myeloid Leukemia

Male or<br/>FemaleGender Male or

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

OnePhase One

60+Age Over 60

Blood<br/>CancersCancer LocationBlood

Systemic therapy | Blood / Myeloma / LymphomaAcute Myeloid Leukaemia

Trial Overview Read MoreRead more

This phase I trial is evaluating the investigational drug, venetoclax, in combination with chemotherapy for the treatment of Acute Myeloid Leukaemia (AML).

This trial is treating patients with Acute Myeloid Leukaemia.

This is a systemic therapy trial.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

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

Scientific Title

A phase Ib clinical evaluation of Venetoclax in combination with chemotherapy in older patients with Acute Myeloid Leukemia

Other Non-Commercial Sponsor

Alfred Health


The primary purpose of this trial is to evaluate the safety and efficacy of venetoclax in combination with chemotherapy for the treatment of acute myeloid leukaemia (AML) in elderly patients. Who is it for? You may be eligible to participate in this trial if you are aged 60 or over with monosomal karyotype, or aged 65 or over with any karyotype, and have been diagnosed with AML for which you have received no induction chemotherapy. Study details All participants enrolled in this trial will be administered Venetoclax in combination with modified-dose chemotherapy. The dose provided will depend on the time of enrolment - each sequentially enrolled group of participants will be administered with a slightly higher dose than the previous group, pending a review of the safety of the previous dose. Participants will have an induction treatment consisting of 14 days Venetoclax tablets, 5 days IV Cytarabine and 2 days IV Idarubicin. For participant achieving a response to treatment there will be up to 4 further cycles of 14 days Venetoclax, 2 days Cytarabine and 1 day Idarubicin or until adequate blood count recovery. Participants will be assessed through blood samples taken daily during initial hospitalisation and then at the end of each cycle of treatment, bone marrow samples taken 3 times during induction and then every other cycle as well as a physical exam every cycle in order for researchers to monitor whether the treatment is safe and whether it is effectively treating the AML. It is hoped that the findings of this trial will provide information on the optimal dose of Venetoclax in combination with chemotherapy for the safe and effective treatment of AML in elderly patients.

Recruiting Hospitals Read MoreRead more

Alfred Hospital, Malignant Haematology & Stem Cell Transplantation Service
Mr John Nguyen
03 9076 7135

Box Hill Hospital, Malignant Haematology
Box Hill
Ms Liz Arnold
03 9094 9516

Not Recruiting Hospitals Read MoreRead more


Austin Health
Ms Samantha Chakar
03 9496 3088

PCCTU (Parkville Cancer Clinical Trials Unit) *
Jessica Ahern

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.