ALLG 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
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Keep this study
Lead
M.D. Anderson Cancer Center
With
Australasian Leukaemia and Lymphoma Group
Primary Objective:
To determine the MRD response of patients with AML to decision-rule guided therapy.
Secondary Objectives:
To determine the durability of the response of patients with AML to decision-rule guided therapy.
A key scientific objective of the study is to investigate the dynamics of MRD response and the duration of clinical benefit in the morphologic and MRD failure strata.
To investigate if duration of MRD response is longer for patients treated at MRD vs morphologic failure. Safety: To characterize the safety and tolerability of targeted therapies (as single agents and in combination with other agents).
To investigate the efficacy of distinct treatment sequences in AML patients who fail one or more lines of therapy on study.
To determine the overall efficacy of the platform as an evolving system for managing patients with AML. Quality of Life.
To investigate patterns and mechanisms of resistance.
To determine the response of patients with AML with morphologic relapse in each treatment arm.
To determine the response of patients with AML with a secondary MRD marker in each treatment arm.
Age
18–55
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
2. the mutation/mutations specified for this treatment arm in Master Protocol Appendix 2.0 Compendium of Actionable Domains and Allocation Rules
2. Meets MRD eligibility for INTERCEPT therapy based on a screening sample taken no more than 42 days prior to cycle 1 of day 1 of treatment on this treatment arm. Refer to Master Protocol Appendix 5 for the definitions of MRD progression/failure. Eligibility will be confirmed by the MRD review committee.
3. ECOG 0-2
4. Patients entering this arm post-allogeneic stem cell transplantation will need to have an absolute lymphocyte count of .0.2 x 109/L and no evidence of active acute graft-versushost disease (GVHD)
5. Subject must have adequate renal function as demonstrated by a creatinine clearance .
30 mL/min; calculated by the Cockcroft Gault formula or measured by 24-hours urine collection 6. Subject must have adequate liver function as demonstrated by:
1. aspartate aminotransferase (AST) . 3.0 \~ ULN
2. alanine aminotransferase (ALT) . 3.0 \~ ULN
3. bilirubin . 1.5 \~ ULN (unless bilirubin rise is due to Gilbert fs syndrome or of nonhepatic origin) 7. Agrees to follow the recommended contraception procedures for this treatment domain
You may not be if
10mg/day prednisolone for graft vs host disease 3. Subject is HIV positive 4. Patients with .5% myeloblasts in bone marrow on morphologic assessment 5. Evidence of other clinically significant uncontrolled condition(s) including, but not limited to:
1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal)
Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (NYHA Grade . 2) with an LVEF of \<40%, uncontrolled hypertension or clinically significant arrhythmia
Acute myocardial infarction or unstable angina pectoris . 3 months prior to study entry 14. Known hypersensitivity to azacitidine or mannitol.
Clareo Health | ALLG 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
