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

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 ID
NCT06982274
Phase
PHASE2
Sponsor
Instituto do Cancer do Estado de São Paulo
Status
RECRUITING
Cancer Type
Leukemia
Interventions
  • Realgar-Indigo Naturalis Formulation
Locations (sample)
  • São Paulo, São Paulo, Brazil|-23.5475,-46.63611

Key Eligibility Criteria

  • Informed consent
  • New diagnosis of APL by cytomorphology, confirmed for molecular analysis
  • Age ≥18 and ≤75 years
  • Serum total bilirubin ≤ 3.0 mg/dl (≤ 51 μmol/l)

For full eligibility, visit ClinicalTrials.gov.

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