At a glance
ClinicalIndex Comparison RecordPhase 2Active· 103 enrolled
Drug / intervention
Azacitidine +1 moredrug
Likely dose
Azacitidine 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2 Study of Cusatuzumab Plus Azacitidine in Patients With Newly Diagnosed Acute Myeloid Leukemia Who Are Not Candidates for Intensive Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Azacitidine and Cusatuzumab for Leukemia, Myeloid, Acute. Active but no longer recruiting, targeting 103 participants across 56 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid, Acute
CountriesAustralia, Brazil, France, Israel, Italy, Russia, Spain, Switzerland, Turkey (Türkiye)
Collaboratorsargenx, Janssen Research & Development, LLC
Timeline
Phase 2ActiveOverdue
2020202120222023202420252026
First PostedJul 2019
Enrollment StartJul 2019
Primary CompletionAug 2023
Study CompletionMay 2026
TodayJul 2026
First PostedJul 17, 2019
Enrollment StartJul 29, 2019
Primary CompletionAug 15, 2023
Study CompletionMay 15, 2026
TodayJul 2, 2026
Enrollment to primary: 4.0 yearsPosted 7.0 years ago
Interventions
Azacitidinedrug
Azacitidine SC or IV will be administered at a standard dose of 75 mg/m\^2 on days 1-7 of each cycle.
Cusatuzumabdrug
Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.