A multicenter, open-label, randomized, phase 2 study of venetoclax and azacitidine plus cusatuzumab versus venetoclax and azacitidine alone in newly diagnosed AML patients who are not candidates for intensive therapy

Phase 1

• Conditions: Acute myeloid leukemia; MedDRA version: 21.0Level: LLTClassification code: 10000886Term: Acute myeloid leukemia Class: 10029104; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2024-510991-19-00
• Lead Sponsor: Oncoverity Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-10
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 177

Inclusion Criteria

Men and women =18 years old., Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study., Diagnosis of AML according to ICC 2022 (with the exclusion of MDS/AML with 10-19% blasts)., Previously untreated AML except may have received emergency leukapheresis, hydroxyurea, and/or 1 dose of 1 to 2 g/m2 cytarabine before study entry to control hyperleukocytosis., Deemed unfit for intensive chemotherapy by meeting the criterial listed in the Protocol, Adequate liver and renal function, as per defined in the Protocol, Women of childbearing potential (WOCBP), defined as fertile women between menarche and post menopause unless permanently sterile, must have a negative highly sensitive serum ß-human chorionic gonadotropin (ß-hCG) or urine pregnancy test at screening, Must be willing to use contraception as consistent with institutional guidelines regarding the use of contraceptive methods for participants participating in clinical studies, Participants with HIV infection are eligible for the trial if the criteria included in the Protocol are met

Exclusion Criteria

Any prior treatment for AML or myelodysplastic syndrome (MDS) (except those outlined in Inclusion Criterion #4), History of prior HSCT, Active hepatitis B or C infection or other clinically active liver diseases as defined in the Protocol, Congestive heart failure severity that is New York Heart Association Class III or IV, Unstable angina, Known allergies, hypersensitivity, or intolerance to cusatuzumab, venetoclax, or azacitidine or their excipients (e.g., mannitol, an excipient of azacitidine), Inability or difficulty swallowing capsules/tablets, malabsorption syndrome, or any disease or medical condition significantly affecting gastrointestinal function, Any condition for which, in the investigator’s opinion, participation would not be in the best interest of the participant (e.g., compromise the well-being) or physical limitations that could prevent, limit, or confound the protocol-specified assessments, Major surgery (e.g., requiring general anesthesia) =4 weeks prior to initiation of study treatment, Participant has received a HMA for MDS or myeloproliferative neoplasm, Leukemic involvement in the central nervous system, Participants with acute promyelocytic leukemia (APL), ECOG performance status of 4 for participants 18 to 74 years of age and ECOG performance status of 3 or 4 for participants =75 years of age, Use of immune suppressive agents =4 weeks before the first administration of cusatuzumab. Participants may be included if free of systemic corticosteroids >5 days before the first administration of cusatuzumab with the exception of corticosteroids at physiologic replacement doses, Received a live, attenuated vaccine within 4 weeks prior to initiation of study drug, Active malignancies (i.e., progressing or requiring treatment change in the last 24 months), including advanced malignant hepatic tumors, other than the disease being treated under study. Exceptions listed in the protocol., Any active systemic infection

Study & Design

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