A study of MBG453 in combination with azacitidine and venetoclax in AML patients unfit for chemotherapy

Phase 1

• Conditions: Acute Myeloid Leukemia (AML) in adult patients unfit for chemotherapy; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-000439-14-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-12-10
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

Inclusion Criteria:
1.Signed informed consent must be obtained prior to participation in the study.
2. Age = 18 years at the date of signing the informed consent form (ICF)
3. Newly diagnosed with AML based on 2016 WHO classification (Arber et al 2016) and not suitable for intensive chemotherapy defined as: age =75, ECOG performance Status 2 or 3, or any of the following comorbidities: severe cardiac comorbidities (including congestive heart failure, LVEF = 50%, chronic stable Angina) , pulmonary comorbidity (DLCO = 65% or FEVI = 65%). moderate hepatic impairment (with total Bilirubin >1.5 to 3x ULN) , renal impairment (eGFR= 30 ml/min/1.73m^2 to 45 30 ml/min/1.73m^2), or other comorbidity incompatible with intensive chemotherapy per Investigator assessment and approved by the Novartis Medical monitor)
4..Not planned for hematopoietic stem-cell transplantation (HSCT)
5..Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 , 2 or 3

Additional inclusion criteria as per full protocol may apply
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 6
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80

Exclusion Criteria

Exclusion Criteria:
1.Prior exposure to TIM-3 directed therapy
2. History of severe hypersensitivity reactions to any ingredient of study drug(s) (azacitidine, venetoclax or MGB453) or monoclonal antibodies (mAbs) and/or their excipients
3.Current use or use within 14 days prior to randomization of systemic, steroid therapy (> 10 mg/day prednisone or equivalent) or any immunosuppressive therapy. Topical, inhaled, nasal, ophthalmic steroids are allowed. Replacement therapy, steroids given in the context of a transfusion are allowed and not considered a form of systemic treatment.
4.Previous treatment at any time, with any of the following antineoplastic agents, approved or investigational; checkpoint inhibitors, venetoclax and hypomethylating agents (HMAs) such as decitabine or azacitidine.
5.Active autoimmune disease requiring systemic therapy (e.g.corticosteroids).
6.Live vaccine administered within 30 days prior to randomization

Other protocol-defined Inclusion/Exclusion may apply.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified