Combining oral arsenic and ATRA for treating newly diagnosed acute promyelocytic leukemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• QTX-2101 (oral arsenic) plus ATRA for adults with low- or intermediate-risk APL

  This Phase 3 trial tests whether an oral arsenic capsule (QTX-2101) combined with ATRA works well and is safe for adults aged 18–70 with newly diagnosed low- or intermediate-risk acute promyelocytic leukemia.

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• Using advanced imaging to detect extramedullary myeloid leukemia in newly diagnosed acute myeloid leukemia patients

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• Combining tretinoin and arsenic trioxide with or without gemtuzumab ozogamicin for treating acute promyelocytic leukemia

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  Recruiting at 5 sites Phase 2 M.D. Anderson Cancer Center · Houston, Texas and 4 other locations · NCT01409161

• Treatment for Children and Adolescents with Acute Promyelocytic Leukemia

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  Recruiting Phase 1 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT02390752

• Evaluating first line treatment for adult acute promyelocytic leukemia with ATO and ATRA

  This study is testing how well a combination of arsenic trioxide and all-trans retinoic acid works as the first treatment for adults with acute promyelocytic leukemia in Argentina.

  Recruiting at 6 sites Grupo Argentino de Tratamiento de la Leucemia Aguda · La Plata, Buenos Aires and 5 other locations · NCT04897490

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.