Two-Drug combo aims to wipe out childhood leukemia faster
NCT ID NCT06533748
First seen Jun 27, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study tests whether giving two targeted immunotherapy drugs (inotuzumab and blinatumomab) together at the start of treatment can eliminate leukemia cells more effectively than standard chemotherapy in children and young adults (ages 1-18) with newly diagnosed B-cell acute lymphoblastic leukemia or lymphoma. The goal is to achieve a deep remission with no detectable cancer cells after about one month of therapy. The trial enrolls 128 participants at high risk of relapse and compares results to previous standard treatments.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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May 2034
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 18 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
3 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Novant Health Presbyterian Hemby Children's Hospital
RECRUITINGCharlotte, North Carolina, 28204, United States
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Saint Francis Children's Hospital
RECRUITINGTulsa, Oklahoma, 74136, United States
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St. Jude Children's Research Hospital
RECRUITINGMemphis, Tennessee, 38105, United States
Contact Email: •••••@•••••
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