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A phase Ib clinical evaluation of Venetoclax in combination with chemotherapy in older patients with Acute Myeloid Leukemia
Other Non-Commercial Sponsor
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.
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.