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

Study acronym: IC-APL2020
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Study description expanded, about 149 words
    • Study title shortened, about 13 words
    v2
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06982274
Lead Sponsor Instituto do Cancer do Estado de São Paulo
Collaborators: American Society of Hematology
Conditions
(from sponsor)		 Acute Promyelocytic Leukemia (APL)
Related terms Leukemia, Promyelocytic, Acute
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov