Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil

NCT05959720 | Recruiting FDA Drug

• 1 other identifier: 3011/22
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

In this project, the investigators intend to start a prospective registry for patients with newly diagnosed Philadelphia-negative ALL from 16 years old and above in participating centers, provided that all patients will be treated with the same regimen (a pediatric regimen BFM-based incorporating peg-asparaginase). All diagnostic/follow-up (after induction and consolidation blocks) samples will be centrally biobanked at Instituto do Cancer do Estado de Sao Paulo. The main goal of this study is to examine whether the implementation of a pediatric protocol under a prospective registry can increase event-free survival (EFS) and overall survival (OS) of newly diagnosed patients in the participating centers.

Conditions

Acute Lymphoid Leukemia; Minimal Residual Disease; Gene Abnormality; Chemotherapeutic Toxicity

Outcome Measures

Primary Outcomes (1)

• Overall survival (OS)

  cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up)

  4 years

Secondary Outcomes (5)

• Event-free survival (EFS)

  4 years

• Early death rate

  60 days

• Complete response rate

  60 days

• Cumulative incidence of relapse

  4 years

• HSCT rate

  2 years

Study Arms (1)

Eligible patients

All patients deemed eligible to intensive protocol of treatment are going to be included as sole group. There is no intervention or control group in this trial.

Drug: Prednisone; Drug: Vincristin; Drug: Daunorubicin; Drug: Peg-asparaginase; Drug: Intrathecal Suspension; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Doxorubicin

Interventions

Prednisone DRUG

60 mg/m2 D1 to D21

Eligible patients

Vincristin DRUG

1.5 mg/m2 D1, D8, D15 and D22

Eligible patients

Daunorubicin DRUG

40 mg/m2 D1, D8, D15 and D22

Eligible patients

Peg-asparaginase DRUG

2000 UI/m2 D12 and D26

Eligible patients

Intrathecal Suspension DRUG

MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29

Eligible patients

Cyclophosphamide DRUG

1000 mg/m2 D36 and D64

Eligible patients

Cytarabine DRUG

75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60

Eligible patients

Mercaptopurine DRUG

30 mg/m2 D36 to D63 and D1 to D56 of consolidation

Eligible patients

Methotrexate DRUG

3.000 mg/m2 D8, D22, D36 and D50

Eligible patients

Doxorubicin DRUG

30 mg/m2 D1 and D22

Eligible patients

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All patients from 16 years and above newly diagnosed with Philadelphia-negative ALL and after the signature of informed consent form (ICF). Patients between 16 and 17 years-old will sign a child assent along with a parental consent form. ICF application might be performed even under ALL suspicion only, given the need for sample collection before any therapy, ideally.

You may not qualify if:

• Burkitt leukemia
• Prior myeloproliferative disease
• Philadelphia chromosome positivity through whichever methodology (RT-PCR, FISH, or conventional karyotype)
• ECOG\>2 (appendix 3)
• Total bilirubin\>2x upper limit of normal (ULN)
• Transaminases\>5x ULN
• Creatinine\>2,5 mg/dl
• Positive serology for HIV or HTLV
• Heart failure NYHA Class III or IV (appendix 4)
• Severe psychiatric disorder which prevents adequate compliance
• Prior treatment with intravenous chemotherapy
• Refusal to participate in the study
• Down syndrome

Sponsors & Collaborators

• Instituto do Cancer do Estado de São Paulo: lead
• Servier: collaborator

Study Sites (1)

Instituto do Cancer do Estado de Sao Paulo

São Paulo, São Paulo, 01246000, Brazil

RECRUITING

Related Publications (1)

• Silva WF, Amano MT, Perruso LL, Cordeiro MG, Kishimoto RK, de Medeiros Leal A, Nardinelli L, Bendit I, Velloso ED, Rego EM, Rocha V. Adult acute lymphoblastic leukemia in a resource-constrained setting: outcomes after expansion of genetic evaluation. Hematology. 2022 Dec;27(1):396-403. doi: 10.1080/16078454.2022.2052602.

  PMID: 35344469 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

All bone marrow or peripheral blood samples from diagnosis are going to be stored in a registered biobank. From bone marrow, DNA, RNA (Trizol) and mononuclear cryopreserved cells are going to be stored after Ficoll separated centrifugation. From peripheral blood, only DNA/RNA from buffy coat.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Neoplasm, Residual

Interventions

Prednisone; Vincristine; Daunorubicin; pegaspargase; Cyclophosphamide; Cytarabine; Mercaptopurine; Methotrexate; Doxorubicin

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; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Sulfhydryl Compounds; Sulfur Compounds; Purines; Aminopterin; Pterins; Pteridines

Study Officials

• Wellington F Silva, MD PhD

  Instituto do Cancer do Estado de São Paulo

  PRINCIPAL INVESTIGATOR

• Eduardo M Rego, MD PhD

  Instituto do Cancer do Estado de São Paulo

  STUDY CHAIR

Central Study Contacts

Graziela Silva

CONTACT

551138934677; graziela.sasilva@hc.fm.usp.br

Bruna Moraes, MSc

CONTACT

551126628112; pesquisa.hematologia@hc.fm.usp.br

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2023
• First Posted: July 25, 2023
• Study Start: September 5, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

BR (1)