Real World Evidence of First Line Treatment With Arsenic Trioxide Plus All Trans Retinoic Acid in Adult Patients With Acute Promyelocytic Leukemia

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• 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

Locations
Other Locations
Argentina
CEMIC
RECRUITING
Caba
FUNDALEU
RECRUITING
Caba
Hospital Italiano de La Plata
RECRUITING
La Plata
Instituto Privado de Hematologia y Hemoterapia
RECRUITING
Paraná
Hospital Escuela de Agudos Dr. Ramón Madariaga
RECRUITING
Posadas
Hospital Descentralizado Dr. Guillermo Rawson
RECRUITING
Rawson
Contact Information
Primary
Federico Sackmann, Dr.
fsackmann@fundaleu.org.ar
+5491149720765
Backup
Paula Freigeiro
gatla.ar@gmail.com
+5491140470052
Time Frame
Start Date: 2021-03-01
Estimated Completion Date: 2026-12
Participants
Target number of participants: 50
Treatments
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.
Authors
María José Mela Osorio
Sponsors
Leads: Grupo Argentino de Tratamiento de la Leucemia Aguda

This content was sourced from clinicaltrials.gov

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