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.
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
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
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
Loading…
Loading trial locations…
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