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

Phase 2

Active, not recruiting

• Conditions: Acute Myeloid Leukemia

• Registration Number: NCT04150029
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-10-22
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Signed informed consent must be obtained prior to participation in the study.<br><br> 2. Age = 18 years at the date of signing the informed consent form (ICF)<br><br> 3. Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not<br> suitable for intensive chemotherapy defined as: age =75, ECOG performance Status 2<br> or 3, or any of the following comomorbitities: severe cardiac comorbities (including<br> congestive heart failure, LVEF = 50%, chronic stable Angina) , pulmonary comorbidity<br> (DLCO = 65% or FEVI = 65%). moderate hepatic impairment (with total Bilirubin >1.5<br> to 3x ULN) , renal impairment (eGFR= 30 ml/min/1.73m^2 to 45 30 ml/min/1.73m^2), or<br> other comorbidity incompatible with intensive chemotherapy per Investigator<br> assessement and approved by the Novartis Medical monitor)<br><br> 4. .Not planned for hematopoietic stem-cell transplantation (HSCT)<br><br> 5. .Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3<br><br>Exclusion Criteria:<br><br> 1. Prior exposure to TIM-3 directed therapy<br><br> 2. History of severe hypersensitivity reactions to any ingredient of study drug(s)<br> (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their<br> excipients<br><br> 3. Current use or use within 14 days prior to randomization of systemic, steroid<br> therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy.<br> Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy,<br> steroids given in the context of a transfusion are allowed and not considered a form<br> of systemic treatment.<br><br> 4. Previous treatment at any time, with any of the following antineoplastic agents,<br> approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating<br> agents (HMAs) such as decitabine or azacitidine.<br><br> 5. Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).<br><br> 6. Live vaccine administered within 30 Days prior to randomization<br><br>Other protocol-defined Inclusion/Exclusion may apply.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of dose limiting toxicities (Safety run-in patients only);Percentage of subjects achieving complete remission (CR)