Clinical Trial

Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia

Study acronym: IC-APL2020
Recruiting Phase 2
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Summary
It is a non-randomized, multicenter, prospective study, aiming to treat patients with newly diagnosed acute promyelocytic leukemia with a combination of oral arsenic and atra, with low dose chemotherapy for those with high-risk disease (white blood cell count above 10x10a9/L). The primary objective is to assess the 2-year overall survival (OS) in these patients, comparing with the historical control group of patients treated with ATRA/chemotherapy according to the IC-APL 2006 protocol.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-05-13.
Trial Details
NCT Number NCT06982274
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators: American Society of Hematology
Conditions Acute Promyelocytic Leukemia (APL)
Enrollment 115 participants
Start Date 2023-10-20
Primary Completion 2028-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2025-05-30