A Study of Cusatuzumab Plus Azacitidine in Participants With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy

• Status: Not yet recruiting
• Trial end date: 2021-04-30
• Target enrollment: 150
• Participant gender: All

Summary

The purpose of this study is to determine the efficacy of cusatuzumab in combination with azacitidine in participants with previously untreated acute myeloid leukemia (AML) who are not eligible for intensive chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Janssen Research & Development, LLC
• Collaborator: argenx BVBA
• Treatments: Azacitidine

Criteria

Inclusion Criteria:

• Acute myeloid leukemia (AML) according to World Health Organisation (WHO) 2016 criteria and fulfilling all of the following criteria that defines "not candidates for intensive chemotherapy": (a) greater than or equal to (>=)75 years of age or (b) Comorbidity of at least one of the following: Eastern Cooperative Oncology Group (ECOG) Performance Status of 2; Severe cardiac comorbidity defined as congestive heart failure or ejection fraction less than or equal to (<=) 50 percent (%); Severe pulmonary comorbidity defined as documented pulmonary disease with lung diffusing capacity for carbon monoxide (DLCO) <=65% of expected, or forced expiratory volume in 1 second (FEV1) <=65% of expected or dyspnea at rest requiring oxygen; Moderate hepatic impairment defined according to NCI organ dysfunction classification criteria (total bilirubin >=1.5 up to 3 times upper limit of normal [ULN]); Creatinine clearance <45 milliliter per minute per 1.73 meter square (mL/ min/1.73 m^2); Comorbidity that, in the Investigator's opinion, makes the participant unsuitable for intensive chemotherapy and must be documented and approved by the Sponsor before randomization; (c) De novo or secondary AML; (d) Previously untreated AML (except: emergency leukapheresis, 1 low dose of cytarabine and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of azacitidine). All trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia is permitted but must be discontinued at least 1 day prior to the start of azacitidine; (e) Not eligible for an allogeneic hematopoietic stem cell transplantation

• ECOG Performance Status score of 0, 1 or 2

Exclusion Criteria:

• Acute promyelocytic leukemia with t (15;17), or its molecular equivalent (Promyelocytic leukemia [PML]-Retinoic acid receptor, alpha [RARalpha])

• Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system

• Use of immune suppressive agents for the past 4 weeks before the first administration of cusatuzumab on Cycle 1 Day 1. For regular use of systemic corticosteroids, participants may only be included if free of systemic corticosteroids for a minimum of 5 days before the first administration of cusatuzumab

• Prior treatment with a hypomethylating agent for treatment of AML or myelodysplastic syndrome (MDS)

• A diagnosis of other malignancy that requires concurrent non surgical treatment

• Any active untreated systemic infection

• Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (that is, mannitol, an excipient of azacitidine)