A Study of MBG453 in Combination With Azacitidine and Venetoclax in AML Patients Unfit for Chemotherapy

Official Title

A Phase II Multi-centre, Single Arm, Safety and Efficacy Study of MBG453 in Combination With Azacitidine and Venetoclax for the Treatment of Acute Myeloid Leukemia (AML) in Adult Patients Unfit for Chemotherapy

Summary:

This trial will seek to extend the preliminary findings of efficacy of MBG453 in combination with hypomethylating agents (HMA) by evaluating MBG453 in combination with the HMA azacitidine and the Bcl-2 inhibitor venetoclax. The primary purpose of Part 1 (Safety Run-in) is to rule out excessive toxicity of MBG453, when administered in combination with azacitidine and venetoclax. The primary purpose of the combined Part 1 and Part 2 (Safety run-in and Expansion Part) is to evaluate efficacy of MBG453, when administered in combination with azacitidine and venetoclax in adult patients with newly diagnosed AML, who are not suitable for treatment with intensive chemotherapy.

Trial Description

Primary Outcome:

• Incidence of dose limiting toxicities (Safety run-in patients only)
• Percentage of subjects achieving complete remission (CR)

• Percentage of subjects achieving a complete remission (CR) or complete remission with incomplete hematologic blood count recovery (CRi)
• Time from date of first documented CR or CRi to the date of first documented relapse or death due to any cause
• Time from the date of the first documented CR to the date of first documented relapse or death due to any cause
• Time from start of treatment until death, relapse from CR, or treatment failure, whichever occurs first
• Time from start of treatment to death due to any cause (overall survival)
• Peak Serum Concentration (Cmax) MBG453
• Trough Serum Concentration (Cmin) MBG453
• Trough Plasma Concentration (Cmin) Venetoclax
• Anti-drug Antibody (ADA) prevalence at baseline
• ADA prevalence on-treatment
• Percentage of MRD-negative subjects in the full study population and in subjects achieving CR or CRi
• Rate of subjects who achieve transfusion independence from baseline and while on treatment.

View this trial on ClinicalTrials.gov