AMLM22/D1: 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 patients with acute myeloid leukaemia in first complete remission.

Phase 2

• Conditions: Acute myeloid leukaemia (AML); Cancer - Leukaemia - Acute leukaemia

• Registration Number: ACTRN12619000248167
• Lead Sponsor: Australian Leukaemia and Lymphoma Group (ALLG)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-19
• Last Update Posted: 7 March 2022

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

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%

1. Meets inclusion criteria outlined in IAPC master protocol. (the above)
2. Platelet count =100 x109/L and neutrophil count =0.5 x 109/

Exclusion Criteria

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

AMLM22/D1 specific exclusion criteria:
1. Presence of any general exclusion criteria outlined in in IAPC master protocol.
2. Prior solid organ transplant.
3. Cardiac abnormalities as evidenced by any of the following:
a. Clinically significant conduction abnormalities or uncontrolled arrhythmia.
b. Greater than or equal to New York Heart Association (NYHA) class II congestive cardiac failure and/or ejection fraction < 50% by echocardiogram (ECHO) or multi gated acquisition scan (MUGA)
c. Unstable angina or myocardial infarction with coronary angioplasty/stenting within the last 3 months
d. ECG findings demonstrating baseline a QTcF interval greater than or equal to 480 ms
4. Increased bleeding risk as a result of:
a. Use of anticoagulants at therapeutic levels within 7 days prior to the first dose of Molibresib (GSK525762).
b. Evidence of active bleeding or major bleed within the last 3 months.
c. Coagulation parameters (prothrombin time/international normalised ratio [PT/INR] and activated partial thromboplastin time [APTT]) greater than or equal to 1.2 x upper limit of normal (ULN)
5. Subject not able to comply with domain-specific contraception recommendations

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure-free survival - this is the time from randomisation until the time of the earliest leukaemia event (relapse). Data to monitor failure-free survival (disease monitoring and MRD testing) will be collected from patient's at various protocol specified times points throughout the study.[Time from randomisation until the time of the earliest leukemia event- either MRD progression, MRD relapse, clinical relapse or death. ]