Actively Recruiting
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Led by St. Jude Children's Research Hospital · Updated on 2026-05-01
128
Participants Needed
2
Research Sites
483 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
P
Pfizer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment on the INITIALL protocol
- Age between 1 and 18.99 years at enrollment
- Diagnosis of B-cell acute lymphoblastic leukemia or lymphoblastic lymphoma
- No prior chemotherapy except that allowed by INITIALL
- Classified as NCI high-risk (age 10 or older or white blood cell count of 50,000 or more) or NCI standard-risk with high-risk clinical features such as CNS3 disease, testicular leukemia involvement, or steroid pretreatment
- For lymphoblastic lymphoma, stage 3-4 disease, or stage 1-2 disease if age 10 or older or with high-risk clinical features
- Adequate liver function: total bilirubin ≤1.5 times normal and ALT ≤5 times normal; if bilirubin elevated due to hemolysis, direct bilirubin must be <1.5 times normal
- Adequate kidney function: glomerular filtration rate ≥50 mL/min/1.73m2 or serum creatinine below age- and sex-specific limits
- For post-induction inclusion: treatment on this trial for induction or prior treatment with slow response or high-risk genetics needing transition to this trial post-induction
You will not qualify if you...
- Presence of ETV6::RUNX1 fusion without high-risk features or slow response to induction
- History or presence of serious central nervous system conditions such as epilepsy, seizures (except simple febrile seizures), stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
- Active uncontrolled infection
- Current or past autoimmune disease with possible CNS involvement
- History of venoocclusive disease or sinusoidal obstructive syndrome
- Unstable heart disease including prolonged QTc interval over 500 msec
- Inability or unwillingness to give informed consent or assent
- Pregnant or lactating
- Patients of reproductive potential unwilling to use effective contraception during therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
2
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Seth E. Karol, MD, MSCI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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