Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
2 other identifiers
interventional
128
1 country
2
Brief Summary
This is a Phase II clinical trial testing the use of two antigen-directed therapies, inotuzumab and blinatumomab, as part of induction therapy for children and young adults with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma. Primary Objective
- To assess if the flow-cytometry assessed MRD-negative remission rate following an immunotherapy-based Induction in NCI-high risk patients without favorable genetic features is higher than the results of similar patients treated on AALL1131. Secondary Objectives
- To compare flow-cytometry assessed MRD-negative rates at the end of Induction for patients treated with this therapy compared to similar patients treated on TOT17.
- To compare the rate of significant toxicities in patients treated with this therapy to those treated with standard-risk therapy on TOT17.
- To assess the event free and overall survival of patients treated with this therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2025
Longer than P75 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2024
CompletedFirst Posted
Study publicly available on registry
August 1, 2024
CompletedStudy Start
First participant enrolled
January 23, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2034
May 1, 2026
April 1, 2026
3.3 years
July 30, 2024
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
End of induction minimal residual disease negative remission
Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint.
On treatment to end of induction, approximately 29 days
Secondary Outcomes (4)
Comparison of MRD-negative rates to those on Total 17
On treatment to end of induction, approximately 29 days
Compare significant toxicities experienced to those on Total 17
On treatment to end of reconsolidation, approximately 56 days.
Event free survival (EFS)
3.5 years after enrollment.
Overall survival (OS)
3.5 years after enrollment.
Study Arms (1)
SJALL23H Treated Patients
EXPERIMENTALAll eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Cyclophosphamide, Dasatinib, IT MHA. Early Post Induction: Cyclophosphamide, Cytarabine, Inotuzumab, Methotrexate, IT MHA, Dasatinib, Blinatumomab, 6-mercaptopurine, Dexamethasone, Vincristine, Daunorubicin, Calaspargase. Maintenance: Dexamethasone, Vincristine, Methotrexate, 6-mercaptopurine, Thioguanine, Dasatinib, IT MHA.
Interventions
Given orally (PO) or intravenously (IV).
Given Intrathecal (IT), Age adjusted.
Given IT, IV, PO or intramuscular (IM).
Given PO (participants intolerant to mercaptopurine).
Eligibility Criteria
You may qualify if:
- Enrollment on INITIALL.
- Age 1-18.99 years at the time of enrollment on INITIALL.
- B-Acute lymphoblastic leukemia or lymphoblastic lymphoma.
- No prior chemotherapy excluding therapy given on or allowed by INITIALL.
- NCI high-risk (age 10 years or greater or presenting WBC count ≥50,000 cells/microL) or NCI standard-risk and a HR clinical feature as listed below:
- CNS3 disease (≥5 WBC/microL CSF with blasts present)
- Testicular involvement of leukemia
- Steroid pretreatment defined as \>24 hours of therapy in the 14 days prior to enrollment on INITIALL if a preceding WBC to define NCI risk is unavailable
- For lymphoblastic lymphoma, Stage 3-4 disease OR Stage 1-2 disease in patient ages ≥10 years OR HR clinical feature as defined above.
- Adequate liver function defined as:
- Total bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. Patients with an elevated total bilirubin due to hemolysis are eligible if they have a direct bilirubin \<1.5x the upper limit of normal.
- Adequate renal function defined as:
- Calculated glomerular filtration rate (GFR) ≥ 50 mL/min/1.73m\^2 using the Bedside Schwartz equation OR creatinine below or equal to the maximum defined below:
- Age: 1 to \<2 years; maximum serum creatinine (mg/dL): 0.6 (male and female)
- Age: 2 to \<6 years; maximum serum creatinine (mg/dL): 0.8 (male and female)
- +10 more criteria
You may not qualify if:
- Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy.
- Active uncontrolled infection.
- Current active autoimmune disease or history of autoimmune disease with the potential for CNS involvement.
- History of venoocclusive disease/ sinusoidal obstructive syndrome.
- Unstable cardiac disease including QTc \>500msec.
- Inability or unwillingness to give informed consent/ assent as applicable.
- Pregnant or lactating.
- For patients of reproductive potential, unwillingness to use effective contraception for the duration of protocol therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- St. Jude Children's Research Hospitallead
- Pfizercollaborator
- Amgencollaborator
Study Sites (2)
Saint Francis Children's Hospital
Tulsa, Oklahoma, 74136, United States
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Seth Karol, MD, MSCI
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 30, 2024
First Posted
August 1, 2024
Study Start
January 23, 2025
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2034
Last Updated
May 1, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.