Actively Recruiting
RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Led by Grupo Argentino de Tratamiento de la Leucemia Aguda · Updated on 2024-01-09
50
Participants Needed
6
Research Sites
300 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
RWE of 1st Line Treatment With ATO/ATRA for Adult APL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older.
- Signed consent form for study participation.
- Diagnosis of acute promyelocytic leukemia (APL) according to World Health Organization criteria, without prior treatment.
- Identification of APL genetic alteration by conventional karyotype, FISH, RT-PCR, or RQ-PCR, with recommended transcript isoforms bcr1, bcr2, or bcr3 to document molecular remission.
You will not qualify if you...
- Presence of other active malignant tumors requiring treatment.
- Previous treatment for APL.
- Electrocardiogram abnormalities including Long QT syndrome, baseline QTc > 450 msec, significant ventricular or atrial tachyarrhythmias (Grade 3-4), or bifascicular blocks.
- ECOG performance status of 4.
- Stage III-IV heart failure.
- Serum creatinine ≥ 2.5 mg/dL unless due to APL.
- Bilirubin ≥ 2.5 mg/dL, alkaline phosphatase, GPT or GOT > 3 times normal unless due to APL.
- Severe psychiatric illness.
- Women who are pregnant or breastfeeding.
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Actively Recruiting
2
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province, Argentina
Actively Recruiting
3
Hospital Escuela de Agudos Dr. Ramón Madariaga
Posadas, Misiones Province, Argentina
Actively Recruiting
4
Hospital Descentralizado Dr. Guillermo Rawson
Rawson, San Juan Province, Argentina
Actively Recruiting
5
CEMIC
CABA, Argentina
Actively Recruiting
6
FUNDALEU
CABA, Argentina
Actively Recruiting
Research Team
F
Federico Sackmann, Dr.
CONTACT
P
Paula Freigeiro
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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