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Clinical trialNCT06533748RecruitingPhase 2Interventional

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

SponsorSt. Jude Children's Research HospitalEnrollment128Acute Lymphoblastic LeukemiaLymphoblastic Lymphoma
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.
clinicaltrials.gov ↗

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

3 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Novant Health Presbyterian Hemby Children'S Hospital

    Charlotte, North Carolina, United States

    Jessica Bell, MD
    Recruiting
  • Saint Francis Children'S Hospital

    Tulsa, Oklahoma, United States

    Ashraf Mohamed, MD
    Recruiting
  • St. Jude Children'S Research Hospital

    Memphis, Tennessee, United States

    Seth E. Karol, MD, MSCI
    Recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Mercaptopurine →Blinatumomab →CALASPARGASECyclophosphamide →Cytarabine →Dasatinib →Daunorubicin →Dexamethasone →INOTUZUMABMethotrexate →ThioguanineVincristine →
Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
23 Jan 2025
Primary completion
31 May 2028
Completion
31 May 2034
Last update posted
16 Jul 2026
Registered enrollment
128
Registry id
NCT06533748
clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.