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Recruiting Phase 2

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

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About this study

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.

Condition
Acute Promyelocytic Leukemia (APL)
Tested
Realgar-Indigo Naturalis Formulation
Sponsor
Instituto do Cancer do Estado de São Paulo

Who can join

Age
18 to 75 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 13

  • Minimum age: 18 years
  • Maximum age: 75 years
  • Study condition: Acute Promyelocytic Leukemia (APL)
  • 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 18

  • 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

1 site, 1 recruiting

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, Brazil

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.