RecruitingPhase 2ACTRN12619000280101

AMLM22/D2-The International Acute myeloid leukaemia (AML) Platform Consortium (IAPC) trial is a randomised, multi-arm study platform to compare the efficacy of experimental therapies versus standard of care in subjects with acute myeloid leukaemia in first complete remission. Domain 2 is investigating the safety and efficacy of Venetoclax as a maintenance therapy alone or in combination with low dose cytarabine (LDAC).

Sponsor

Australian Leukaemia and Lymphoma Group (ALLG)

Enrollment

75 participants

Start Date

Jul 8, 2020

Study Type

Interventional

Conditions

Acute Myeloid Leukaemia (AML)

Summary

This study will evaluate the safety and efficacy of venetoclax alone or in combination with low-dose cytarabine (LDAC) for Acute Myeloid Leukemia Who is it for? You may be eligible to join this study if you are aged 16 and above and have Acute Myeloid Leukemia in first complete remission. Study details This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated (by chance) to one of three treatment groups. Participants in one group will receive standard care which is generally observation. Participants in the other groups will receive the drug Venetoclax daily for a total of 24 months or Venetoclax in combination with low-dose cytarabine (LDAC) for a total of 24 months. As part of the study, participants will have blood tests at the start of each cycle (every 28 days) as well as additional blood tests depending on the treatment arm you have been randomised to. These additional blood tests are to monitor the level of neutrophils (type of white blood cell that is important in fighting infection) and platelets (platelets help your blood clot) We hope that the results from this trial will be used to help these new treatments which may be better for people with AML than what is currently available become accessible to the general population at faster than the normal process.

Eligibility

Sex: Both males and femalesMin Age: 16 Yearss

Plain Language Summary

Simplified for easier understanding

Acute myeloid leukaemia (AML) is an aggressive blood cancer that requires intensive chemotherapy. While many patients achieve remission after initial treatment, the disease frequently returns — and there are currently very few proven options for maintaining remission. This trial is investigating two maintenance therapies to try to prevent relapse: venetoclax alone, and venetoclax combined with low-dose cytarabine. This study is part of a large international research platform. Participants who have achieved their first complete remission after chemotherapy will be randomly assigned to one of three groups: standard care (observation only), venetoclax daily for 24 months, or venetoclax plus low-dose cytarabine for 24 months. Blood tests will be done regularly to monitor blood counts and safety. You may be eligible if you are 16 years of age or older, have been diagnosed with AML (excluding a specific subtype called APL), and have achieved your first complete remission with bone marrow blasts below 5% after intensive chemotherapy. People with prior stem cell transplants, HIV, active hepatitis B or C, significant uncontrolled infections, or a planned stem cell transplant in the next three months would not be eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Domain 2 is AMLM22/D2, it has 3 treatment arms: Arm 1: Venetoclax (investigational product) plus Low-dose cytarabine (LDAC). Recommended dose of Venetoclax is 600mg daily, taken orally on days 1-28 o

Domain 2 is AMLM22/D2, it has 3 treatment arms: Arm 1: Venetoclax (investigational product) plus Low-dose cytarabine (LDAC). Recommended dose of Venetoclax is 600mg daily, taken orally on days 1-28 of each cycle. Low dose cytarabine (LDAC) is given subcutaneously (under the skin) at a dose of 20mg/m2 daily on days 1-10 of each 28-day cycle, following administration of venetoclax. Each cycle is 28 days. Total treatment duration is expected to be 24 months. Arm 2: Venetoclax monotherapy. Recommended dose of Venetoclax is 800mg daily, taken orally on days 1-28 of each cycle. Each cycle is 28 days. Total treatment duration is expected to be 24 months. Arm 3: Standard of care (generally observation) Patients randomised to receive venetoclax will be asked to return any unused tablets at each visit.