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

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 observational clinical trial aims to gather real-world evidence on the treatment outcomes of adult patients diagnosed with acute promyelocytic leukemia (APL) in Argentina who receive arsenic trioxide (ATO) and all-trans retinoic acid (ATRA) as first-line therapy. The study will follow patients prospectively to assess event-free survival and overall survival, as well as secondary endpoints such as complete molecular response rates and treatment-related toxicity. Patients will be categorized into risk groups based on their white blood cell counts, and treatment regimens will be adjusted accordingly, including the potential use of idarubicin for high-risk patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

Exclusion Criteria:

* Presence of other concomitant active malignant tumors that require simultaneous treatment.
* Having received prior treatment for APL.
* Electrocardiogram abnormalities:

  1. Patients with a pre-existing diagnosis of Long QT Syndrome
  2. 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).
  3. Patients with a history or presence of significant ventricular or atrial tachyarrhythmia (Grade 3-4, CTCAE v5.2017).
  4. 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's running

• Hospital Italiano de La Plata
  La Plata, Buenos Aires, Argentina Recruiting
• Instituto Privado de Hematologia y Hemoterapia
  Paraná, Entre Ríos Province, Argentina Recruiting
• Hospital Escuela de Agudos Dr. Ramón Madariaga
  Posadas, Misiones Province, Argentina Recruiting
• Hospital Descentralizado Dr. Guillermo Rawson
  Rawson, San Juan Province, Argentina Recruiting
• Cemic
  Caba, Argentina Recruiting
• Fundaleu
  Caba, Argentina Recruiting

Study contacts

• Principal investigator: María José Mela Osorio, Dr. — Grupo Argentino de Tratamiento de la Leucemia Aguda
• Study coordinator: Federico Sackmann, Dr.
• Email: fsackmann@fundaleu.org.ar
• Phone: +5491149720765

Similar studies

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

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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.