Actively Recruiting
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Led by Instituto do Cancer do Estado de São Paulo · Updated on 2025-05-30
115
Participants Needed
1
Research Sites
314 weeks
Total Duration
On this page
Sponsors
I
Instituto do Cancer do Estado de São Paulo
Lead Sponsor
A
American Society of Hematology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Oral Arsenic With ATRA for Newly Diagnosed Patients With Acute Promyelocytic Leukemia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Newly diagnosed acute promyelocytic leukemia confirmed by cytomorphology and molecular analysis
- Age between 18 and 75 years
- Serum total bilirubin less than or equal to 3.0 mg/dl (≤ 51 µmol/l)
- Serum creatinine less than or equal to 3.0 mg/dl (≤ 260 µmol/l)
- Women must be postmenopausal, have had hysterectomy or bilateral oophorectomy, use effective contraception, practice sexual abstinence, or have a vasectomized partner
You will not qualify if you...
- High-risk patients not eligible for chemotherapy as judged by the treating physician
- Age below 18 or above 75 years
- Presence of another active malignancy at study entry
- Lack of genetic confirmation of diagnosis
- Significant heart rhythm problems or ECG abnormalities including congenital long QT syndrome, serious tachyarrhythmias, resting bradycardia below 50 bpm, QTc greater than 500 ms, or specific conduction blocks
- High-risk patients with heart function below 50% ejection fraction
- Uncontrolled or potentially fatal infections
- Severe lung or heart disease
- Severe liver or kidney dysfunction
- Known HIV or hepatitis C infection
- Pregnant or breastfeeding women
- Allergy to study medication or its ingredients
- Substance abuse or conditions interfering with study participation or outcome assessment
- Use of other investigational drugs within 30 days before enrollment
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, Brazil, 01246000
Actively Recruiting
Research Team
E
Elaine Uehara
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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