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

Recruiting now

Conditions studied: Promyelocytic Leukemia, Adult Acute

In brief

This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of acute promyelocytic leukemia (APL) patients in the first line with arsenic trioxide and all trans retinoic acid (ATO/ATRA) based regimens in Argentina.

Key facts

Study ID

NCT04897490

Run by

Grupo Argentino de Tratamiento de la Leucemia Aguda

People needed

50

Starts

2021-03-01

Expected to finish

2026-12-01

Last updated by the study team

2024-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Presence of other concomitant active malignant tumors that require simultaneous treatment.
• Having received prior treatment for APL.
• 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.
• ECOG score 4.
• Stage III-IV heart failure.
• 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.
• Severe psychiatric illness.
• Women who are pregnant or who have decided to continue breastfeeding.

Where it is running

• Hospital Italiano de La Plata — La Plata, Buenos Aires, Argentina (enrolling)
• Instituto Privado de Hematologia y Hemoterapia — Paraná, Entre Ríos Province, Argentina (enrolling)
• Hospital Escuela de Agudos Dr. Ramón Madariaga — Posadas, Misiones Province, Argentina (enrolling)
• Hospital Descentralizado Dr. Guillermo Rawson — Rawson, San Juan Province, Argentina (enrolling)
• CEMIC — CABA, Argentina (enrolling)
• FUNDALEU — CABA, Argentina (enrolling)

Full record on ClinicalTrials.gov

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