Evaluating first line treatment for adult acute promyelocytic leukemia with ATO and ATRA
Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia
This study is testing how well a combination of arsenic trioxide and all-trans retinoic acid works as the first treatment for adults with acute promyelocytic leukemia in Argentina.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Grupo Argentino de Tratamiento de la Leucemia Aguda Academic / other |
| Locations | 6 sites (La Plata, Buenos Aires and 5 other locations) |
| Trial ID | NCT04897490 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 years or older who have been newly diagnosed with acute promyelocytic leukemia and have not received prior treatment.
Not a fit: Patients with other active malignant tumors requiring simultaneous treatment or those with pre-existing electrocardiogram abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment outcomes and survival rates for patients with acute promyelocytic leukemia.
How similar studies have performed: While this approach is based on established treatments, the real-world evidence gathering aspect is relatively novel in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
La Plata, Buenos Aires and 5 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.