RECRUITING

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

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

SJALL23H: Combination Antigen-Directed Induction Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma

Quick Facts

Study Start:2025-02

Study Completion:2034-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06533748

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:1 Year to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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: * Direct bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age. * Patients with ALT or aspartate transferase (AST) 2.5-5x the upper limit of normal for age are ineligible unless the increase is attributable to hemolysis. * 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.	* 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.

Inclusion Criteria

Exclusion 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:
* Direct bilirubin ≤ 1.5x the upper limit of normal for age and alanine transaminase (ALT) ≤ 5x the upper limit of normal for age.
* Patients with ALT or aspartate transferase (AST) 2.5-5x the upper limit of normal for age are ineligible unless the increase is attributable to hemolysis.
* 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.

* 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.

Contacts and Locations

Study Contact

Seth E. Karol, MD, MSCI

CONTACT

866-278-5833

referralinfo@stjude.org

Principal Investigator

Seth Karol, MD, MSCI

PRINCIPAL_INVESTIGATOR

St. Jude Children's Research Hospital

Study Locations (Sites)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

United States

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02

Study Completion Date2034-05

Study Record Updates

Study Start Date2025-02

Study Completion Date2034-05

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Acute Lymphoblastic Leukemia
Lymphoblastic Lymphoma