NCT04897490Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Jan 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 50 (estimated)
- First submitted
- 18 May 2021
- Start date
- 1 Mar 2021
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Grupo Argentino de Tratamiento de la Leucemia Aguda
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT04897490
What you commit to
- Study type: Observational
- Planned participants: 50
- From 1 Mar 2021 to the primary completion date, 1 Jul 2026
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of other concomitant active malignant tumors that require simultaneous treatment.
- Having received prior treatment for APL.
Other illness
- Stage III-IV heart failure.
- Severe psychiatric illness.
Lab values
- 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.
Other
- ECOG score 4.
- Women who are pregnant or who have decided to continue breastfeeding.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CEMIC Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| FUNDALEU Coordinator of this site? Confirm its status | CABA | Argentina | Recruiting |
| Hospital Italiano de La Plata Coordinator of this site? Confirm its status | La Plata | Argentina | Recruiting |
| Instituto Privado de Hematologia y Hemoterapia Coordinator of this site? Confirm its status | Paraná | Argentina | Recruiting |
| Hospital Escuela de Agudos Dr. Ramón Madariaga Coordinator of this site? Confirm its status | Posadas | Argentina | Recruiting |
| Hospital Descentralizado Dr. Guillermo Rawson Coordinator of this site? Confirm its status | Rawson | Argentina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.