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AMLM26- INTERCEPT (Investigating Novel Therapy to Target Early Relapse and Clonal Evolution as Pre-emptive Therapy in AML): A Multi-arm, Precision-based, Recursive, Platform Trial - The Master Protocol
Australasian Leukaemia and Lymphoma Group (ALLG)
Participants enter the study in first or second morphologic remission (CR or CRi) with known and trackable MRD marker(s). The relevant MRD marker(s) will be monitored as per standard practice until evidence of MRD failure and/or morphological relapse. Participants will then be allocated to the best available treatment option at the time. If there is more than one treatment option of equal value for the participant, they will be randomised to one option. As this is a platform trial, new treatment arms may be added and others may be removed if ineffective. New targeted treatment domains may be created when there is sufficient evidence available to enable biomarker-driven enrichment cohorts to be accrued to more rapidly. In domains with a single treatment arm, proof of concept analyses of the primary efficacy endpoint will commence after the first 10 patients have had the required assessments or withdrawn earlier. In domains with more than one treatment arm and with a pre-planned comparison of the arms, the timing of the first analysis will be determined when these arms are added to the trial and information included in the specific treatment arm's linked ANZCTR entry.