NCT06664879

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

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• AML

Interventions

Type	Name	Description
DRUG	MBG-453 + Azacitidine	Given intravenously (by vein)

Timeline

• Start date: 2024-12-30
• Primary completion: 2026-07-31
• Completion: 2028-07-31
• First posted: 2024-10-30
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study