Status:
RECRUITING
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Lead Sponsor:
St. Jude Children's Research Hospital
Collaborating Sponsors:
Pfizer
Amgen
Conditions:
Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Eligibility:
All Genders
1-18 years
Phase:
PHASE2
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...
Detailed Description
This study utilizes a single arm phase II design. Treatment will consist of 3 main phases: Induction, early post induction \[including Consolidation, Blinatumomab 1, High-Dose Methotrexate, Reinductio...
Eligibility Criteria
Inclusion
- 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)
- Age: 6 to \<10 years; maximum serum creatinine (mg/dL): 1.0 (male and female)
- Age: 10 to \<13 years; maximum serum creatinine (mg/dL): 1.2 (male and female)
- Age: 13 to \<16 years; maximum serum creatinine (mg/dL): 1.5 (male); 1.4 (female)
- Age: ≥16 years; maximum serum creatinine (mg/dL): 1.7 (male); 1.4 (female)
- Eligibility for inclusion post-induction requires meeting the first 4 Inclusion criteria above AND:
- Treatment on SJALL23H for Induction OR
- Lymphoblastic lymphoma, initially treated on an SJALL protocol OR standard (non-protocol) therapy, without a complete response at the end of induction OR
- NCI-SR ALL at diagnosis and treated with an SJALL protocol OR standard (non-protocol) therapy who have
- Slow response to therapy (≥0.1% MRD at end of induction for patients with hyperdiploid ALL or ≥0.01% MRD at end of induction for others with ALL) OR
- HR genetics as defined in the protocol.
- These patients may receive no more than 2 weeks of post-induction therapy and should be transitioned to SJALL23H post-induction as soon as the qualifying genetic or MRD result is available.
Exclusion
- Presence of ETV6::RUNX1 fusion unless also having a HR clinical feature OR slow response to induction therapy.
- History or presence of clinically relevant central nervous system (CNS) pathology or event such as epilepsy, childhood or adult non-febrile seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. History of simple febrile seizure during childhood and presence of CNS leukemia at diagnosis are not exclusions to participation.
- 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.
Key Trial Info
Start Date :
January 23 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2034
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT06533748
Start Date
January 23 2025
End Date
May 1 2034
Last Update
September 4 2025
Active Locations (2)
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1
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States, 74136
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105