Brief Summary
The aim is to demonstrate that targeting rising minimal residual disease (MRD) in patients with progressive acutenew, recent, comes with an urgent or significant sense, is sudden, sharp myeloid leukemia (AML) may be an effective approach to maintaining patients in remissiona reduction or absence of symptoms in disease, can be partial or complete for longer. The trial will also determine if a range of novel treatments aimed at targeting MRD will result in improved treatment outcomes.
Intervention/Treatment
Varies based on treatment arm.
- AMLM26/T1 INTERCEPT:
- Drug: Gilteritinib.
- Drug: Venetoclax.
- AMLM26/T2 INTERCEPT:
- Drug: Ivosidenib.
- Drug: Venetoclax.
- AMLM26/T3 INTERCEPT:
- Drug: Low-dose cytarabine (LDAC).
- Drug: Venetoclax.
- AMLM26/T4 INTERCEPT:
- Drug: SNDX5613.
- AMLM26/T5 INTERCEPT:
- Drug: MBG453.
- Drug: Azacitidine.
- AMLM26/T9 INTERCEPT:
- Drug: PHI-101.
Inclusion Criteria
For study entry:
- diagnosisthe process of identifying a disease based on signs and symptoms, patient history and medical test results of AML in first or second CR/CRi.
- a diagnostic baseline bone marrowsoft, spongy tissue found in bones that makes blood cells and/or bloodthe red bodily fluid that transports oxygen and other nutrients around the body sample suitable for DNA/RNA-based studies is available.
- presence of molecular and/or flow cytometric MRD marker(s) at AML diagnosis.
To commence active treatment:
- WBC <25 x 10^9/L (hydroxyurea permitted for WCC control).
- for initial therapy on trial patient must have evidence of morphologic relapsethe return of disease or molecular progression/relapse.
- for patients on trial rotating to other therapies – must have evidence of progressive disease, treatment failure or relapse.
There will be additional arm specific eligibility criteria which will be specified in the domain-specific protocols. For more information, please refer to individual treatment arm pages.