Clinical trial · Observational
RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia
NCT04897490CI-TRIAL-00072852recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Promyelocytic Leukemia, Adult Acute | Adult Acute Promyelocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Evaluation of first line treatment with ATO/ATRA outcome | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adult APL in first line
- description
- Patients \>/= 18 years old with recent diagnosis of acute promyelocytic leukemia who receive treatment with ATO/ATRA according to our local guidelines. HR patients will receive 2-3 additional doses of idarubicin.
- interventionNames
- Other: Evaluation of first line treatment with ATO/ATRA outcome
Primary outcomes (2)
- measure
- Evaluate overall survival of patients diagnosed with APL and treated in first line with ATO/ATRA or ATO/ATRA/Idarubicin (IDA).
- timeFrame
- 36 months
- description
- Evaluate overall survival of patients \>/= 18 years old diagnosed with APL and treated in first line with ATO/ATRA or ATO/ATRA/Idarubicin (IDA) depending on risk category.
- measure
- Evaluate event free survival of patients diagnosed with APL and treated in first line with ATO/ATRA or ATO/ATRA/Idarubicin (IDA).
- timeFrame
- 36 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.