Back to search results

Study of Immunotherapy for Newly Diagnosed B-Cell Leukemia and Lymphoma

This study is for children and young adults (ages 1 to 18) newly diagnosed with B-cell precursor acute lymphoblastic leukemia (a type of blood cancer) or lymphoblastic lymphoma. It's testing a new way to use two immunotherapy drugs, inotuzumab and blinatumomab, along with standard chemotherapy drugs like dexamethasone, vincristine, and dasatinib. The main goal is to see if this treatment can lead to more patients having no signs of cancer cells (minimal residual disease negative remission) at the end of the first month of treatment. You may be eligible if you meet certain risk criteria for your leukemia or lymphoma and have not had prior chemotherapy. The study's current status is unclear, and it plans to enroll 128 participants.

Study design
This is a single-arm Phase II study, meaning all participants receive the same treatment. It aims to enroll 128 participants.
What's involved
Participants will receive treatment in three main phases: Induction, early post-Induction (including several cycles of therapy), and Maintenance. The Induction phase alone involves 7 days on a separate protocol, followed by 5 weeks of treatment on this trial, including daily oral or intravenous medications and weekly intravenous infusions.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome is measured at the end of induction, which is approximately 29 days after starting treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06533748

Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Recruiting
PHASE2Ages 1–18InterventionalTreatment
St. Jude Children's Research Hospital
~128 participants
Updated 2026-07-16 on ClinicalTrials.gov
What's tested:DexamethasoneVincristineInotuzumabBlinatumomabDasatinibIT MHA

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
End of induction minimal residual disease negative remission
Measured over On treatment to end of induction, approximately 29 days

Conditions

Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma

Explore related trials

Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma

Where it's being run

3 sites across 3 states
North Carolina1
Oklahoma1
Tennessee1

Study leadership

  • Seth Karol, MD, MSCI · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Seth E. Karol, MD, MSCI
[email protected]
888-226-4343
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
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)
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.

What this trial measures

  • End of induction minimal residual disease negative remissionOn treatment to end of induction, approximately 29 days

    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.