Acute Lymphoid LeukemiaBRALLANCT05959720
Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil
An observational study of Acute Lymphoid Leukemia and Minimal Residual Disease, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 16 to 50 years
- Conditions the study is for
- Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality
- What is being tested?
- Prednisone, Vincristin and Daunorubicin
- How many people
- 180 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Sep 2023to Jun 2030
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Instituto do Cancer do Estado de Sao Paulo
São Paulo, São Paulo, 01246000
Wellington F Silva, MD PhD, 551138944677, wellington.fernandes@hc.fm.usp.br
About this study
Official title: Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
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.
Read the detailed description
Notably, pediatric regimens for adult acute lymphoblastic leukemia (ALL) have resulted in better long-term outcomes, especially in the Philadelphia-negative counterpart. These regimens are essentially based on higher cumulative doses of asparaginase and the use of less myelotoxic agents, applying allogeneic transplantation only for high-risk ALL subsets. Recent metanalysis encompassing 27 clinical trials demonstrated an improved prognosis when these regimens are adopted. In adults, incorporation of these regimens has been hampered by a perception of higher toxicity and a more complex design, especially with asparaginase. Remarkably, this drug might bring side effects not usually seen with other cancer drugs, such as thrombosis, liver, and pancreatic toxicities. In addition, the incorporation of minimal residual disease (MRD) monitoring throughout the treatment protocol in a scheduled and standardized manner is considered paramount in the contemporary ALL treatment. Treating adult patients with acute leukemia under prospective studies allows accurate data collection and positively impacts the disease prognosis, creating a cooperative scientific environment. In Brazil, few data are available on the clinical- laboratory characteristics of ALL in adults and their outcomes under a standardized treatment protocol. Few single-center reports point to a worse overall survival rate when compared to developed countries. There is great heterogeneity across the centers regarding the treatment regimens and genetic/MRD assessment. 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. At the diagnosis, a genetic characterization encompassing conventional karyotype, fluorescent in-situ hybridization (FISH), and molecular biology in our central laboratory will be performed to classify the cases. Genomic classification will include identifying Philadelphia- like B-cell ALL cases, a recent group of cases with worse prognosis, whose incidence seems higher in Hispanics. In Brazil, there is no study addressing this incidence and, more importantly, evaluating its impact on outcomes under a standardized treatment protocol. MRD analysis will also be centralized to standardize and validate our flow cytometry panel in a homogeneous cohort. Additionally, the investigators plan to assess baseline factors predictive of survival and relapse and those related to major toxicities such as infections, liver toxicity, and thrombosis.
- Conditions
- Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity
- Being tested
- Prednisone, Vincristin, Daunorubicin, Peg-asparaginase, Intrathecal Suspension
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrednisoneDrug
60 mg/m2 D1 to D21
VincristinDrug
1.5 mg/m2 D1, D8, D15 and D22
DaunorubicinDrug
40 mg/m2 D1, D8, D15 and D22
Peg-asparaginaseDrug
2000 UI/m2 D12 and D26
Intrathecal SuspensionDrug
MTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29
CyclophosphamideDrug
1000 mg/m2 D36 and D64
CytarabineDrug
75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60
MercaptopurineDrug
30 mg/m2 D36 to D63 and D1 to D56 of consolidation
MethotrexateDrug
3.000 mg/m2 D8, D22, D36 and D50
DoxorubicinDrug
30 mg/m2 D1 and D22
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Prednisone; Drug: Vincristin; Drug: Daunorubicin; Drug: Peg-asparaginase; Drug: Intrathecal Suspension; Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Doxorubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up)
Measured: 4 years
Secondary outcomes (5)
Event-free survival (EFS)
time between enrollment in the study and the occurrence of any event: refractoriness after the first two cycles of induction, death or relapse.
Measured: 4 years
Early death rate
proportion of patients who died before the first bone marrow evaluation of response (after induction I)
Measured: 60 days
Complete response rate
proportion of patients with bone marrow aspirate with less than 5% blasts and evidence of normal hematopoiesis; CSF without blasts and recovery of peripheral blood (neutrophils≥ 1,000/μL and platelets≥100,000/μL), without the need for transfusion
Measured: 60 days
Cumulative incidence of relapse
rate of disease relapse after CR calculated considering death as a competing event.
Measured: 4 years
HSCT rate
proportion of patients eligible for the protocol who were able to perform the procedure in their first CR
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start5 Sep 2023
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Servier
- Responsible party
- Principal investigator, Wellington Fernandes, Instituto do Cancer do Estado de São Paulo
- Investigators
- Wellington F Silva, MD PhD, Principal investigator, Instituto do Cancer do Estado de São PauloEduardo M Rego, MD PhD, Study chair, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05959720
- Sponsor's protocol ID
- 3011/22
- Acronym
- BRALLA
- Status last verified
- Nov 2026
- First submitted
- 17 Jul 2023
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 35344469
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adult Acute Lymphoblastic Leukemia Treated With Pediatric Regimen in Brazil - a Prospective Collaborative Study
- ClinicalTrials.gov ID
- NCT05959720
- Acronym / sponsor ID
- BRALLA / 3011/22
- Conditions
- Acute Lymphoid Leukemia, Minimal Residual Disease, Gene Abnormality, Chemotherapeutic Toxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Collaborators
- Servier
- Study start
- 5 Sep 2023 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 25 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Notably, pediatric regimens for adult acute lymphoblastic leukemia (ALL) have resulted in better long-term outcomes, especially in the Philadelphia-negative counterpart. These regimens are essentially based on higher cumulative doses of asparaginase and the use of less myelotoxic agents, applying allogeneic transplantation only for high-risk ALL subsets. Recent metanalysis encompassing 27 clinical trials demonstrated an improved prognosis when these regimens are adopted. In adults, incorporation of these regimens has been hampered by a perception of higher toxicity and a more complex design, especially with asparaginase. Remarkably, this drug might bring side effects not usually seen with other cancer drugs, such as thrombosis, liver, and pancreatic toxicities. In addition, the incorporation of minimal residual disease (MRD) monitoring throughout the treatment protocol in a scheduled and standardized manner is considered paramount in the contemporary ALL treatment. Treating adult patients with acute leukemia under prospective studies allows accurate data collection and positively impacts the disease prognosis, creating a cooperative scientific environment. In Brazil, few data are available on the clinical- laboratory characteristics of ALL in adults and their outcomes under a standardized treatment protocol. Few single-center reports point to a worse overall survival rate when compared to developed countries. There is great heterogeneity across the centers regarding the treatment regimens and genetic/MRD assessment. 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. At the diagnosis, a genetic characterization encompassing conventional karyotype, fluorescent in-situ hybridization (FISH), and molecular biology in our central laboratory will be performed to classify the cases. Genomic classification will include identifying Philadelphia- like B-cell ALL cases, a recent group of cases with worse prognosis, whose incidence seems higher in Hispanics. In Brazil, there is no study addressing this incidence and, more importantly, evaluating its impact on outcomes under a standardized treatment protocol. MRD analysis will also be centralized to standardize and validate our flow cytometry panel in a homogeneous cohort. Additionally, the investigators plan to assess baseline factors predictive of survival and relapse and those related to major toxicities such as infections, liver toxicity, and thrombosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Eligible patients | – | Drug: Prednisone, Drug: Vincristin, Drug: Daunorubicin, Drug: Peg-asparaginase, Drug: Intrathecal Suspension, Drug: Cyclophosphamide, Drug: Cytarabine, Drug: Mercaptopurine, Drug: Methotrexate, Drug: DoxorubicinAll 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. |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prednisone60 mg/m2 D1 to D21 | Drug | Eligible patients |
| Vincristin1.5 mg/m2 D1, D8, D15 and D22 | Drug | Eligible patients |
| Daunorubicin40 mg/m2 D1, D8, D15 and D22 | Drug | Eligible patients |
| Peg-asparaginase2000 UI/m2 D12 and D26 | Drug | Eligible patients |
| Intrathecal SuspensionMTX 12 mg, Dexamethasone 2 mg, Cytarabine 60 mg D1, D8, D15, D22, D29 | Drug | Eligible patients |
| Cyclophosphamide1000 mg/m2 D36 and D64 | Drug | Eligible patients |
| Cytarabine75 mg/m2 D36 to D39, D43 to D46, D50 to D53 and D57 to D60 | Drug | Eligible patients |
| Mercaptopurine30 mg/m2 D36 to D63 and D1 to D56 of consolidation | Drug | Eligible patients |
| Methotrexate3.000 mg/m2 D8, D22, D36 and D50 | Drug | Eligible patients |
| Doxorubicin30 mg/m2 D1 and D22 | Drug | Eligible patients |
Primary outcome
Overall survival (OS)
Time frame: 4 years
cumulative proportion of patients alive (considering the time between the date of diagnosis and death or last follow-up)
5 secondary outcomes
Event-free survival (EFS)
Time frame: 4 years
Early death rate
Time frame: 60 days
Complete response rate
Time frame: 60 days
Cumulative incidence of relapse
Time frame: 4 years
HSCT rate
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Background: PubMed 35344469Silva 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.
- Individual participant dataSharing planned: Undecided
Related trials for Acute Lymphoid Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wellington F Silva, MD PhD principal investigator
Instituto do Cancer do Estado de São Paulo
Eduardo M Rego, MD PhD study chair
Instituto do Cancer do Estado de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoid Leukemia and Minimal Residual Disease, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Graziela Silva (551138934677, graziela.sasilva@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05959720, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.