Combining oral arsenic and ATRA for treating newly diagnosed acute promyelocytic leukemia
Combination of Oral Arsenic With ATRA and Minimal-Dose Chemotherapy for Newly Diagnosed Patients With Acute Promyelocytic Leukemia: a Study by the International Consortium on APL
This study is testing if a new treatment combining oral arsenic and ATRA can help newly diagnosed patients with acute promyelocytic leukemia live longer and feel better, especially those at high risk.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 115 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Instituto do Cancer do Estado de São Paulo Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (São Paulo, São Paulo) |
| Trial ID | NCT06982274 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective study aims to treat newly diagnosed patients with acute promyelocytic leukemia (APL) using a combination of oral arsenic and all-trans-retinoic acid (ATRA). For high-risk patients, defined as having a white blood cell count above 10x10⁹/L, low-dose chemotherapy will also be administered. The primary goal is to assess the 2-year overall survival rate in these patients compared to historical controls treated with ATRA and chemotherapy. Secondary objectives include evaluating response rates, disease-free survival, and toxicity profiles, among others.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a new diagnosis of acute promyelocytic leukemia confirmed by cytomorphology and molecular analysis.
Not a fit: Patients with other active malignancies or those who are not eligible for chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment approach could significantly improve survival rates for patients with acute promyelocytic leukemia.
How similar studies have performed: Previous studies have shown promising results with ATRA in treating APL, but the combination with oral arsenic is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 eligible for inclusion in the study: Postmenopausal (12 months of amenorrhea or 6 months of amenorrhea with serum FSH \> 40 U/ml); After undergoing hysterectomy or bilateral oophorectomy; Continuous and correct use of a contraceptive method with a Pearl Index \<1% (e.g., implants, oral contraceptives, intrauterine devices); Sexual abstinence; Vasectomy of sexual partner. Exclusion Criteria: * High-risk patients who are not eligible for chemotherapy according to the judgment of the treating physician; * Age \<18 or \>75 years * Other active malignancy at the time of study entry * Lack of diagnostic confirmation at the genetic level * Significant arrhythmias, ECG abnormalities, or neuropathy: Congenital long QT syndrome; History or presence of significant ventricular or atrial tachyarrhythmia; Clinically significant resting bradycardia (\<50 beats per minute); QTc \> 500 ms on ECG screening for both sexes; Right bundle branch block with left anterior hemiblock or bifascicular block * High-risk patients with other cardiac contraindications for intensive chemotherapy (LVEF \< 50%) * Uncontrolled and potentially fatal infections * Severe uncontrolled pulmonary or cardiac disease * Severe hepatic or renal dysfunction * Known HIV and/or hepatitis C infection * Pregnant or breastfeeding women * Allergy to the study drug or excipients in the study medication * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study or the assessment of study outcomes * Use of other investigational drugs at the time of enrollment or within 30 days before study entry.
Where this trial is running
São Paulo, São Paulo
- Instituto do Cancer do Estado de Sao Paulo — São Paulo, São Paulo, Brazil (Recruiting)
Study contacts
- Principal investigator: Eduardo M Rego, MD PhD — Instituto do Cancer do Estado de Sao Paulo
- Study coordinator: Elaine Uehara
- Email: elaine.uuehara@hc.fm.usp.br
- Phone: 55 38933535
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.