RWE of Pediatric-like Protocol for AYA Patients With Ph-negative ALL

NCT05127148 | Recruiting

• 1 other identifier: GATLA 11-LLA Ph(-)-20 AYA
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, observational real world clinical trial with prospective follow up that will evaluate the treatment outcome of adolescent and young patients with ph-negative acute lymphoblastic leukemia with first-line pediatric-like protocol in Argentina.

Conditions

Acute Lymphoblastic Leukemia, Adult

Keywords

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (3)

• Evaluate event free survival of AYA Ph-negative ALL patients treating in first line depending on risk category.

  Evaluate event free survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.

  36 months

• Evaluate overall survival of AYA Ph-negative ALL patients treating in first line depending on risk category.

  Evaluate overall survival of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.

  36 months

• Evaluate toxicities of AYA Ph-negative ALL patients treating in first line depending on risk category.

  Evaluate toxicities of AYA Ph-negative ALL patients treating in first line with pediatric-like protocol depending on risk category.

  36 months

Secondary Outcomes (3)

• Evaluate survival in patients who underwent allogeneic transplantation in first remission

  36 months

• Evaluate asparaginase toxicities.

  36 months

• Assess central cerebrospinal fluid involvement by flow cytometry.

  36 months

Study Arms (1)

Adolescents and young adults Ph-negative ALL patients in first-line

Adolescents and young adults patients (18-40 years old) with recent diagnosis of Ph-negative acute lymphoblastic leukemia who receive argentinian pediatric-like treatment depending on risk category.

Other: Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category.

Interventions

Evaluation of survival and toxicities in AYA Ph-negative ALL patients treating in first line depending on risk category. OTHER

Evaluation of survival (event free survival and overall survival) and toxicities in AYA Ph-negative ALL patients treating in first line with argentinian pediatric-like protocol depending on risk category.

Adolescents and young adults Ph-negative ALL patients in first-line

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All AYA (18-40 years old) with recent diagnosis of ph-negative ALL without previous treatment.

You may qualify if:

• Signature of the form consent for participation in the study
• Ph-negative ALL diagnosis without previous treatment.

You may not qualify if:

• ALL with mature B phenotype (sIg +) or with the cytogenetic alterations characteristic of ALL mature B (t (8,14), t (2, 8), t (8, 22)).
• Ph-positive ALL
• Acute leukemias of ambiguous lineage (undifferentiated or mixed phenotype).
• Patients with a history of coronary, valvular or hypertensive heart disease, that contraindicate the use of anthracyclines.
• Patients with chronic liver disease in the activity phase and / or Bilirubin\> 2 mg / dl and / or transaminases 5 times the normal limit, not related to ALL.
• Patients with severe chronic respiratory failure.
• Renal failure and / or creatininemia\> 2 mg / dl not related to ALL.
• Serious neurological disorders, not related to leukemic disease.
• General condition affected (grades 3 and 4), not attributable to ALL.
• Uncontrolled infection by HIV, HTLV-1, HBV, HCV.
• Patient not a candidate for treatment based on the criteria of the treating physician.
• Pregnant women will have to be evaluated by a multidisciplinary team and an ethics committee.

Sponsors & Collaborators

• Grupo Argentino de Tratamiento de la Leucemia Aguda: lead

Study Sites (2)

Instituto Privado de Hematologia y Hemoterapia

Paraná, Entre Ríos Province, Argentina

RECRUITING

FUNDALEU

CABA, Argentina

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Maria Moirano, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

• Isolda Fernández, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  STUDY CHAIR

• Luciana Ferrari, Dr.

  Grupo Argentino de Tratamiento de la Leucemia Aguda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciana Ferrari, Dr.

CONTACT

541148771000; lferrari@fundaleu.org.ar

Paula Freigeiro

CONTACT

5491140470052; gatla.ar@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 60 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2021
• First Posted: November 19, 2021
• Study Start: March 1, 2021
• Primary Completion: March 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 (2)