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

Recruiting Phase 2 Interventional Study
Acute Promyelocytic Leukemia (APL)
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
115 (estimated)
Sponsor
Instituto do Cancer do Estado de São Paulo · Other
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About This Trial
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 contr…
Trial Locations
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Eligibility Criteria
Inclusion 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) * Serum creatinine ≤ 3.0 mg/dl (≤ 260 μmol/l) * Women must meet at least one of the following criteria to be el…
Contacts

Elaine Uehara

55 38933535

elaine.uuehara@hc.fm.usp.br

CONTACT