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.
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
Presence of other concomitant active malignant tumors that require simultaneous treatment.
Having received prior treatment for APL.
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).
Adult patients with APL in first line treatment
Cohort
Prospective
Evaluation of first line treatment with ATO/ATRA outcome
Other interventionEvaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.
Evaluate overall survival of patients diagnosed with APL and treated in first line with ATO/ATRA or ATO/ATRA/Idarubicin (IDA).
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.
Evaluate event free survival of patients diagnosed with APL and treated in first line with ATO/ATRA or ATO/ATRA/Idarubicin (IDA).
Evaluate event free 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.
Evaluate complete molecular remission rate at the end of the consolidation treatment.
Evaluate toxicity of the ATO/ATRA scheme (+/- IDA), measured according to type, frequency, severity and relation with the treatment of adverse events.
Record early mortality (within 30 days of admission).
Evaluate whether the presence of mutated FLT3 has prognostic value in patients treated with ATRA/ATO.
The prognostic value will be analyzed by comparing rates of complete remission (CR), hematological relapse, molecular relapse, PFS and OS.
Click on the lead sponsor to view all of their trials.
