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

Summary

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.

Eligibility

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.

Conditions2

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