RWE of 1st Line Treatment With ATO/ATRA for Adult APL

Korábbi kezelés

• Presence of other concomitant active malignant tumors that require simultaneous treatment.
• Having received prior treatment for APL.

Más betegség

• Stage III-IV heart failure.
• Severe psychiatric illness.

Laborértékek

• Electrocardiogram abnormalities:
  • Patients with a pre-existing diagnosis of Long QT Syndrome
  • Patients with a baseline QTc of\> 450msec. The Bazett formula should be used to measure the corrected QT interval (QT interval in msec divided by the square root of the RR interval in msec).
  • Patients with a history or presence of significant ventricular or atrial tachyarrhythmia (Grade 3-4, CTCAE v5.2017).
  • Patients with right bundle branch block plus left anterior hemiblock. Bifascicular blocks are excluded.
• Serum creatinine ≥ 2.5 mg / dL (≥ 250 μmol / L) unless due to APL.
• Bilirubin ≥ 2.5 mg / dL, alkaline phosphatase, GPT or GOT\> 3 times the normal limit unless it is for APL.

Egyéb

• ECOG score 4.
• Women who are pregnant or who have decided to continue breastfeeding.

• Patients 18 years or older.
• Signature of the form consent for participation in the study.
• Diagnosis of APL (either primary or secondary) according to the criteria of the World Health Organization (WHO), without prior treatment.
• Identification of the specific genetic alteration of APL by conventional karyotype, fluorescent in situ hybridization (FISH), reverse transcriptase polymerase chain reaction (RT-PCR or RQ-PCR). Identification of the transcript is recommended at the time of diagnosis isoforms: bcr1, bcr2, bcr3 essential to document the therapeutic response: Molecular remission