AML
Conditions
Brief summary
To demonstrate the efficacy of targeted and tailored sequential therapy in patients with AML.
Detailed description
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.
Interventions
DRUGMBG-453 + Azacitidine
Given intravenously (by vein)
Sponsors
M.D. Anderson Cancer Center
Australasian Leukaemia and Lymphoma Group
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Meets inclusion criteria outlined in the AMLM26 INTERCEPT Master Protocol including: 1. Master Protocol Inclusion Criteria listed in Master Protocol Appendix 3.0. 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
Exclusion criteria
Presence of any general
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Adverse Events (AEs) | Through study completion; an average of 1 year | Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORCourtney DiNardo, MD
M.D. Anderson Cancer Center
Outcome results
None listed