Observes first-line arsenic and retinoic acid treatment in adults with acute promyelocytic leukemia
Studies outcomes of arsenic trioxide with retinoic acid in adults with acute promyelocytic leukemia.
Plain-language title generated from the registry record
Registry title: RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Key facts
- Where
- CABA, La Plata, Paraná, Posadas, and Rawson, ArgentinaSee the 6 sites
Where in Argentina
- CEMICCABA, ArgentinaTaking people
- FUNDALEUCABA, ArgentinaTaking people
- Hospital Italiano de La PlataLa Plata, ArgentinaTaking people
- Instituto Privado de Hematologia y HemoterapiaParaná, ArgentinaTaking people
- Hospital Escuela de Agudos Dr. Ramón MadariagaPosadas, ArgentinaTaking people
- Hospital Descentralizado Dr. Guillermo RawsonRawson, ArgentinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Trial code
- NCT04897490
- Record updated
- 9 January 2024
- Original description
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.Read full original descriptionShow less
Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia
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.
Inclusion: 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: Presence of other concomitant active malignant tumors that require simultaneous treatment; Having received prior treatment for APL; Stage III-IV heart failure; Severe psychiatric illness; 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; ECOG score 4; Women who are pregnant or who have decided to continue breastfeeding.