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RecruitingLast updated: 13 May 2024

AMLM22/D2: This study will evaluate the safety and efficacy of a targeted therapy drug (called venetoclax) alone, or in combination with low-dose chemotherapy (called cytarabine), for the treatment of Acute Myeloid LeukaemiaThe 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).

Clinical summary

Summary

This study is part of the International AML Platform Consortium. Participants in this study will be randomly allocated 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 oral drug venetoclax daily for a total of 24 months, or venetoclax in combination with low-dose cytarabine (LDAC) for a total of 24 months. Cytarabine will be given subcutaneously (under the skin) on days 1-10 of each cycle. 

As part of this 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 (a type of white blood cell that is important in fighting infection) and platelets (platelets help your blood clot). 

It is hoped 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 faster than the normal process.

This study is linked to another (AMLM22/D1: ACTRN12619000248167p) as both are sub-studies of the main platform study.

Conditions

This trial is treating patients with acute myeloid leukaemia in first complete remission after intensive chemotherapy

Cancer

Blood Cancers Haematological

Age

People16+

Phase

II

Trial Acronym

AMLM22/D2

More information

Trial Identifiers

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Trial sponsor

Australian Leukaemia and Lymphoma Group (ALLG), Abbvie Pty Ltd

Scientific Title

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).

Eligibility

Inclusion

 

1. Provision of written informed consent
2. Provision of written informed consent to the ALLG NBCR
3. Age 18+ (Age 16-17 permitted if consent for minor PICF approved by the authorizing HREC)
4. AML (excluding APL) in first complete remission with bone marrow blasts <5%
5. Subject has achieved remission after intensive chemotherapy (e.g. 7+3 or equivalent +/- subsequent consolidation therapy)
6. ECOG 0-2
7. Subject must have adequate renal function as demonstrated by a creatinine clearance greater than or equal to 30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection
8. Subject must have adequate liver function as demonstrated by:
a. aspartate aminotransferase (AST) greater than or equal to 3.0 × ULN
b. alanine aminotransferase (ALT) greater than or equal to 3.0 × ULN
c. bilirubin greater than or equal to 1.5 × ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin)
9. Agrees to follow the recommended contraception procedures for this treatment domain

Exclusion

1. Chemotherapy or investigational agents within 28 days of planned study cycle 1 day
2. Impaired hematologic recovery 8 weeks after last chemotherapy
a. Grade 2 anemia (Hb <100g/L)
b. Grade 4 neutropenia (N <0.5 x 109/L)
c. Grade 3 thrombocyotopenia (Plt <50 x 109/L)
3. History of other malignancy requiring active systemic treatment or which is likely to result in an expected survival time of < 2 years
4. Viral infection with known HIV or viral hepatitis type B or C not adequately controlled by antiviral medication
5. Prior bone marrow or stem cell transplantation
6. There is an intent to undertake a stem cell transplant procedure within the next 3 months
7. Subject is HIV positive
8. 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.
9. 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 inducers
c. Moderate or strong cytochrome CYP3A inhibitors may be used with caution with appropriate dose modifications for venetoclax
10. 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
11. Subject not able to comply with domain-specific contraception recommendations

Inclusion

  • You are able to swallow medication by mouth.
  • You have had a certain type of treatment or surgical procedure.

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.
Message

Clinical trials have complex eligibility criteria.

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

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