Clinical trial · Observational
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoid Leukemia | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Gene Abnormality | — | UNRESOLVED | — |
| Minimal Residual Disease | — | UNRESOLVED | — |
Interventions
Interventions (10)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Doxorubicin | Drug | Doxorubicin | ALIAS |
| Intrathecal Suspension | Drug | — | UNRESOLVED |
| Mercaptopurine | Drug | Mercaptopurine | ALIAS |
| Methotrexate | Drug | Methotrexate | ALIAS |
| Peg-asparaginase | Drug | Pegaspargase | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Eligible patients
- description
- 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.
- interventionNames
- Drug: Prednisone
- Drug: Vincristin
- Drug: Daunorubicin
- Drug: Peg-asparaginase
- Drug: Intrathecal Suspension
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Mercaptopurine
- Drug: Methotrexate
- Drug: Doxorubicin
Primary outcomes (1)
- measure
- Overall survival (OS)
- timeFrame
- 4 years
- description
- cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up)
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Patients between 16 and 50 years-old with newly diagnosed ALL, negative for Philadelphia chromosome not previously treated (except for hydroxyurea, corticosteroids, or intrathecal chemotherapy) with 20% or more lymphoblasts in bone marrow or peripheral blood. Exclusion Criteria: * 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
References
Publications (1)
- BACKGROUNDSilva 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