RWE of 1st Line Treatment With ATO/ATRA for Adult APL

NCT04897490 | Recruiting

• 1 other identifier: GATLA 11-LPA-20
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Promyelocytic Leukemia, Adult Acute

Keywords

Acute Promyelocytic Leukemia; ATRA; ATO; IDA

Outcome Measures

Primary Outcomes (2)

• 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.

  36 months

• 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.

  36 months

Secondary Outcomes (4)

• Evaluate complete molecular remission rate at the end of the consolidation treatment.

  36 months

• Evaluate toxicity of the ATO/ATRA scheme (+/- IDA), measured according to type, frequency, severity and relation with the treatment of adverse events.

  36 months

• Record early mortality (within 30 days of admission).

  Within 30 days of admission

• Evaluate whether the presence of mutated FLT3 has prognostic value in patients treated with ATRA/ATO.

  36 months

Study Arms (1)

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.

Other: Evaluation of first line treatment with ATO/ATRA outcome

Interventions

Evaluation of first line treatment with ATO/ATRA outcome OTHER

Evaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.

Adult APL in first line

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients with APL in first line treatment

You may qualify if:

• 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

You may not qualify if:

• Presence of other concomitant active malignant tumors that require simultaneous treatment.
• Having received prior treatment for APL.
• 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.
• 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.

Sponsors & Collaborators

• Grupo Argentino de Tratamiento de la Leucemia Aguda: lead

Study Sites (6)

Hospital Italiano de La Plata

La Plata, Buenos Aires, Argentina

RECRUITING

Instituto Privado de Hematologia y Hemoterapia

Paraná, Entre Ríos Province, Argentina

RECRUITING

Hospital Escuela de Agudos Dr. Ramón Madariaga

Posadas, Misiones Province, Argentina

RECRUITING

Hospital Descentralizado Dr. Guillermo Rawson

Rawson, San Juan Province, Argentina

RECRUITING

CEMIC

CABA, Argentina

RECRUITING

FUNDALEU

CABA, Argentina

RECRUITING

MeSH Terms

Conditions

Leukemia, Promyelocytic, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid, Acute; Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• María José Mela Osorio, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

• Isolda Fernández, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  STUDY CHAIR

• Federico Sackmann, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Federico Sackmann, Dr.

CONTACT

+5491149720765; fsackmann@fundaleu.org.ar

Paula Freigeiro

CONTACT

+5491140470052; gatla.ar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2021
• First Posted: May 21, 2021
• Study Start: March 1, 2021
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will become available on June 2021, and will remain available until the end of the clinical trial.

Locations

AR (6)