Recruiting

Phase 2

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

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06533748

Conditions

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Vincristine

Inotuzumab

Blinatumomab

Dasatinib

Study Details

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 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

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Study ID

NCT06533748

Start date

Jan 23, 2025

Status verified date

Jul, 2026

Completion date

May, 2034

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

128 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SJALL23H Treated Patients

All eligible patients receive intervention according to the Detailed Description section with the following:

Induction: Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Cyclophosphamide, Dasatinib, IT MHA.

Early Post Induction: Cyclophosphamide, Cytarabine, Inotuzumab, Methotrexate, IT MHA, Dasatinib, Blinatumomab, 6-mercaptopurine, Dexamethasone, Vincristine, Daunorubicin, Calaspargase.

Maintenance: Dexamethasone, Vincristine, Methotrexate, 6-mercaptopurine, Thioguanine, Dasatinib, IT MHA.

Interventions

Dexamethasone

Given orally (PO) or intravenously (IV).

Vincristine

Given IV.

Inotuzumab

Given IV.

Blinatumomab

Given IV.

Dasatinib

Given PO.

IT MHA

Given Intrathecal (IT), Age adjusted.

Cyclophosphamide

Given IV.

Cytarabine

Given IV or IT.

Methotrexate

Given IT, IV, PO or intramuscular (IM).

6-Mercaptopurine

Given PO.

Calaspargase

Given IV.

Daunorubicin

Given IV.

Thioguanine

Given PO (participants intolerant to mercaptopurine).

Primary outcome measure

End of induction minimal residual disease negative remission [ Time Frame: On treatment to end of induction, approximately 29 days ]

Central Contacts and Locations

Central contacts

Seth E. Karol, MD, MSCI

888-226-4343 referralinfo@stjude.org

Locations

Novant Health Presbyterian Hemby Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Jessica Bell, MD

704-384-1900 jbell@novanthealth.org

Principal Investigator:

Jessica Bell, MD

Saint Francis Children's Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Ashraf Mohamed, MD

918-502-6720 ammohamed@saintfrancis.com

Principal Investigator:

Ashraf Mohamed, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Seth E. Karol, MD, MSCI

888-226-4343 referralinfo@stjude.org

Principal Investigator:

Seth E. Karol, MD, MSCI

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 16, 2026

Last verified

Jul, 2026

Keywords

Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma
Newly Diagnosed
Antigen-directed therapies
Induction therapy
Children
Young Adults

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-16.