Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2021-03-01
2026-12-31
Brief Summary
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Detailed Description
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Every APL patient diagnosed in our institutions will follow our guidelines with respect to diagnosis procedures. Risk category will depend on white blood cell counts (WBC), where WBC \>10000 will be considered high risk (HR) and \<10000 WBC, low risk (LR).
Patients will receive induction with ATO plus ATRA daily until hematologic remission or for a maximum of 60 days, followed by ATO 5 days/week, 4 weeks on 4 weeks off, for a total of 4 courses and ATRA 2 weeks on and 2 weeks off for a total of 7 courses.
HR patients will receive 2-3 doses of IDA at the beginning of induction. Central nervous system prophylaxis is contemplated for HR pts or those who have SNC bleeding.
Molecular response will be evaluated at the end of consolidation by RQ-PCR. LR patients who achieve CMR will not need to repeat molecular evaluations but HR patients will need RQ-PCR evaluation every 3 months during the first year and every 6 months during the second year.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Adult APL in first line
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.
Evaluation of first line treatment with ATO/ATRA outcome
Evaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.
Interventions
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Evaluation of first line treatment with ATO/ATRA outcome
Evaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Grupo Argentino de Tratamiento de la Leucemia Aguda
OTHER
Responsible Party
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Principal Investigators
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María José Mela Osorio, Dr.
Role: PRINCIPAL_INVESTIGATOR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Isolda Fernández, Dr.
Role: STUDY_CHAIR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Federico Sackmann, Dr.
Role: PRINCIPAL_INVESTIGATOR
Grupo Argentino de Tratamiento de la Leucemia Aguda
Locations
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Hospital Italiano de La Plata
La Plata, Buenos Aires, Argentina
Instituto Privado de Hematologia y Hemoterapia
Paraná, Entre Ríos Province, Argentina
Hospital Escuela de Agudos Dr. Ramón Madariaga
Posadas, Misiones Province, Argentina
Hospital Descentralizado Dr. Guillermo Rawson
Rawson, San Juan Province, Argentina
CEMIC
CABA, , Argentina
FUNDALEU
CABA, , Argentina
Countries
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Central Contacts
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Facility Contacts
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Hernán Dick, Dr.
Role: primary
Pedro Negri Aranguren, Dr.
Role: primary
Diego Wolhein, Dr.
Role: primary
María Celina Vanina, Dr.
Role: primary
Nicolás Cazap, Dr.
Role: primary
Federico Sackmann, Dr.
Role: primary
Other Identifiers
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GATLA 11-LPA-20
Identifier Type: -
Identifier Source: org_study_id
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