At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I-II, Multicentre, Open Label Clinical Trial to Assess the Safety and Tolerability of the Combination of Low-dose Cytarabine or Azacitidine, Plus Venetoclax and Quizartinib in Newly Diagnosed Acute Myeloid Leukemia Patients Aged Equal or More Than 60 Years Old Ineligible for Standard Induction Chemotherapy
In Brief
A Phase 2 clinical trial evaluating Azacitidine, Venetoclax, and 2 other interventions for Leukemia, Myeloid, Acute and 2 related conditions. Completed, enrolled 113 participants across 15 sites.
Detailed Summary
A phase I-II trial based on the combination of three drugs regimen LDAC or Azacitidine + Venetoclax + Quizartinib that in this population could be well tolerated by a sequential type administration. The first objective is to achieve rapid control of the disease, using two different schemes, one based in Azacitidine and the other in LDAC, by dose escalation in phase I of the trial. The second goal is to prevent relapse through a maintenance schedule. Phase II will study the efficacy and safety of the recommended dose for Phase II
Study Details
Timeline
Interventions
AZA 75 mg/m2/daily SC days 1 to 7 or on a 5-on/2-off \[weekend\]/2-on schedule in 28-day cycle
Venetoclax (ramp-up) 400 mg/daily oral days 1 to 28
Quizartinib 40 mg/daily oral, days, 8 to 28
Low-dose subcutaneous cytarabine (LDAC) 20 mg/m2/daily SC, days 1 to 10
Venetoclax (ramp-up) 600 mg/daily oral, days 1 to 28
Quizartinib 40 mg/daily oral, days 8 to 28