New treatment for children and young adults with newly diagnosed B-cell leukemia and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the effectiveness of two antigen-directed therapies, inotuzumab and blinatumomab, as part of the induction therapy for children and young adults diagnosed with B-cell precursor acute lymphoblastic leukemia and lymphoma. The study aims to determine if these therapies can achieve a higher rate of minimal residual disease (MRD)-negative remission compared to previous treatments. Participants will undergo a structured treatment regimen that includes multiple phases: induction, early post-induction, and maintenance. The trial also assesses the safety and survival outcomes associated with this new treatment approach.

Why it matters

Who can join: the full rules

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.

Where it's running

• Novant Health Presbyterian Hemby Children's Hospital
  Charlotte, North Carolina, United States Recruiting
• Saint Francis Children's Hospital
  Tulsa, Oklahoma, United States Recruiting
• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Seth Karol, MD, MSCI — St. Jude Children's Research Hospital
• Study coordinator: Seth E. Karol, MD, MSCI
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Strength Training for Kids with Acute Lymphoblastic Leukemia and Lymphoblastic L lymphoma

  Researchers are testing a structured strength-training program for children and teens recently diagnosed with ALL or lymphoblastic lymphoma to see if it helps with weight gain and physical function during treatment.

  Recruiting UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT07634653

• Child and Young Adult (CAYA) Cancer Outcomes Review

  This project looks at past treatment results to see what affects outcomes for children and young adults (ages 0–21) with leukemia and other cancers treated at participating centers in low- and middle-income countries.

  Recruiting at 5 sites Resonance, Inc. · Yerevan and 6 other locations · NCT07246213

• CMV Triplex vaccine to boost immunity and prevent CMV after haploidentical stem cell transplant

  This trial tests whether giving a CMV-MVA Triplex vaccine to donors and/or recipients, with or without the antiviral letermovir, can boost CMV immunity and prevent CMV viremia in people having haploidentical stem cell transplants.

  Recruiting at 3 sites Phase 1 City of Hope Medical Center · Duarte, California and 2 other locations · NCT07020533

• Vitamin A and D supplementation for patients undergoing allogeneic hematopoietic transplantation

  This study is testing if giving high doses of vitamins A and D before a stem cell transplant can help patients with certain blood cancers have fewer complications like infections and graft-versus-host disease.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT06508099

• Comparing two conditioning regimens for haploidentical stem cell transplantation

  This study is testing two different treatment plans for patients getting stem cell transplants from partially matched donors to see which one works better in preventing complications like graft failure and relapse.

  Recruiting Phase 2 St. Petersburg State Pavlov Medical University · Saint Petersburg · NCT06477549

• Treatment for Chronic Lymphocytic Leukemia using modified T cells

  This study is testing a new treatment using modified T cells to see if it can help people with chronic lymphocytic leukemia that hasn't responded to other therapies.

  Recruiting Phase 1/2 National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT06364423

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.