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RecruitingNCT06533748Updated Jul 16, 2026

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

A Phase 2 interventional study of Dexamethasone and Vincristine in Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, sponsored by St. Jude Children's Research Hospital. Recruiting at 3 sites in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-07-16.

Sponsored by St. Jude Children's Research Hospital · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 8 months later.
Phase
Phase 2
Study type
Interventional
Enrollment
128
Allocation
Not applicable
Ages
1 Year to 18 Years
Sex
All
01

Study 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.
Read the detailed description

This study utilizes a single arm phase II design. Treatment will consist of 3 main phases: Induction, early post induction [including Consolidation, Blinatumomab 1, High-Dose Methotrexate, Reinduction, Interim, Reconsolidation, and Blinatumomab 2], and Maintenance.

Induction:

  • Induction includes 7 days of therapy on the INITIALL classification protocol (NCT06289673) as well as 5 further weeks of treatment on this trial. Treatment includes 15 days of oral (PO) or intravenous (IV) dexamethasone, 3 weekly doses of vincristine IV, and 2 doses of inotuzumab IV on Days 2 and 8. Patients will then receive blinatumomab IV from Days 9-36. Dasatinib PO will be added beginning on Day 12 for patients with an ABL-class fusion including patients with Ph+ ALL. These patients will also receive dasatinib in all subsequent cycles of therapy. Intrathecal (IT) MHA will be given. Patients will have a week without chemotherapy at the end of Induction, although patients with Induction failure (MRD ≥5% disease) will proceed directly to consolidation. Patients unable to receive inotuzumab by day 3 receive cyclophosphamide IV on days 3-4.

Early Post Induction:

  • Consolidation will be given following completion of Remission Induction Therapy. Patients receive cyclophosphamide intravenous (IV), cytarabine IV, inotuzumab IV, intrathecal (IT) MHA, and dasatinib PO for patients with ABL-class fusion. Patients will have a week without chemotherapy at the end of Consolidation.
  • Blinatumomab 1 will be given with IT MHA for four weeks to all patients after recovery from Consolidation.
  • High-dose Methotrexate will be given IV every two weeks for four cycles. Patients will also receive an IT MHA with each of the 2 week cycles and will take oral mercaptopurine continuously if tolerated.
  • Reinduction will consist of dexamethasone for 7 days in the first and third week, 3 weekly doses of vincristine IV, 1 dose of daunorubicin IV, 1 dose of calaspargase IV, intrathecal (IT) MHA one dose, and dasatinib PO daily (for patients with ABL-class fusion).
  • Interim includes mercaptopurine po daily for 6 weeks, dexamethasone for 1 week (5 days), daunorubicin and vincristine IV on day 1 of weeks 2 and 5, calaspargase IV on day 1 of weeks 1 and 4, IT MHA on day 1 of week 4 and dasatinib po daily for 6 weeks (for patients with ABL-class fusion). Patients will have a week without chemotherapy at the end of Interim Therapy. Patients with Down syndrome will not receive daunorubicin during this phase.
  • Reconsolidation will repeat therapy given in Consolidation but replace the investigational inotuzumab with traditional mercaptopurine.
  • Blinatumomab 2 will be given for four weeks to patients without clonal IgH rearrangements, those with end of Induction MRD, those in whom next-generation based sequencing MRD is unavailable, patients who did not receive blinatumomab during induction, or patients with Down syndrome after Reconsolidation.

Maintenance therapy follows Reconsolidation or Blinatumomab 2 (for those patients receiving this therapy) and includes 8 pulses of dexamethasone and vincristine given every 4 weeks, weekly methotrexate, daily mercaptopurine, intrathecal therapy, and dasatinib (for patients with ABL-class fusions). Maintenance therapy lasts a total of 80 weeks.

Duration of therapy is approximately 2¼ years. Follow-up is recommended until the patient is in remission for 10 years and is at least 18 years old.

02

Conditions studied

  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma

Keywords

  • Acute Lymphoblastic Leukemia
  • Lymphoblastic Lymphoma
  • Newly Diagnosed
  • Antigen-directed therapies
  • Induction therapy
  • Children
  • Young Adults
03

In context

Precursor Cell Lymphoblastic Leukemia-Lymphoma

2,061 studies on the registry are indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma; 490 are open to participants now.

This study's planned enrollment of 128 is above the median of 40 across 1,653 interventional studies indexed under Precursor Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor Cell Lymphoblastic Leukemia-Lymphoma studies →

Lead sponsor

St. Jude Children's Research Hospital is the lead sponsor of 434 studies on the registry; 99 are open to participants now.

Of its 60 completed or terminated interventional studies of FDA-regulated products, 35 (58%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
128 participants (estimated)

Study 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.

    Drug: Dexamethasone · Drug: Vincristine · Drug: Inotuzumab · Drug: Blinatumomab · Drug: Dasatinib · Procedure: IT MHA · Drug: Cyclophosphamide · Drug: Cytarabine · Drug: Methotrexate · Drug: 6-Mercaptopurine · Drug: Calaspargase · Drug: Daunorubicin · Drug: Thioguanine

Interventions

  • DrugDexamethasone

    Given orally (PO) or intravenously (IV).

    Also known as: Decadron, Hexadrol®

  • DrugVincristine

    Given IV.

    Also known as: Vincristine Sulfate, Oncovin

  • DrugInotuzumab

    Given IV.

    Also known as: Inotuzumab ozogamicin, BESPONSA®

  • DrugBlinatumomab

    Given IV.

    Also known as: BLINCYTO®

  • DrugDasatinib

    Given PO.

    Also known as: Sprycel®

  • ProcedureIT MHA

    Given Intrathecal (IT), Age adjusted.

    Also known as: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

  • DrugCyclophosphamide

    Given IV.

    Also known as: Cytoxan®

  • DrugCytarabine

    Given IV or IT.

    Also known as: Cytosine arabinoside, Ara-C

  • DrugMethotrexate

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

    Also known as: MTX, Trexall®

  • Drug6-Mercaptopurine

    Given PO.

    Also known as: Mercaptopurine, 6-MP

  • DrugCalaspargase

    Given IV.

    Also known as: ASPARLAS

  • DrugDaunorubicin

    Given IV.

    Also known as: Daunomycin

  • DrugThioguanine

    Given PO (participants intolerant to mercaptopurine).

    Also known as: 6-thioguanine, Tabloid®

06

What researchers measure

Primary outcomes

  1. End of induction minimal residual disease negative remission

    Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint.

    Time frame: On treatment to end of induction, approximately 29 days

Secondary outcomes

  1. Comparison of MRD-negative rates to those on Total 17

    Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease will be compared between patients enrolled on this trial and patients with similar clinical features (age, WBC at diagnosis, CNS status, testicular involvement) enrolled on Total 17(NCT03117751).

    Time frame: On treatment to end of induction, approximately 29 days

  2. Compare significant toxicities experienced to those on Total 17

    We will compare CTCAE version 5 clinically significant, non-hematological grade 3 or any non-hematological grade 4-5 toxicities. This comparison will encompass 3 periods: induction/ consolidation, reinduction, and reconsolidation.

    Time frame: On treatment to end of reconsolidation, approximately 56 days.

  3. Event free survival (EFS)

    Kaplan-Meier estimates of the survival functions for event-free survival (EFS) will be calculated along with standard error. For EFS, death due to any cause, any relapse, consolidation failure, and second malignancy are considered as failure; patients remaining failure-free at the last follow up are censored.

    Time frame: 3.5 years after enrollment.

  4. Overall survival (OS)

    Kaplan-Meier estimates of the survival functions for overall survival (OS) will be calculated along with standard error. For OS, only death due to any cause is considered as failure and patients still alive at the last follow up are censored.

    Time frame: 3.5 years after enrollment.

07

Study locations

3 of 3 sites recruiting
  • Novant Health Presbyterian Hemby Children's Hospital
    Charlotte, North Carolina 28204, United States
    • Jessica Bell, MD · Contact · jbell@novanthealth.org · 704-384-1900
    • Jessica Bell, MD · Principal investigator
    Recruiting
  • Saint Francis Children's Hospital
    Tulsa, Oklahoma 74136, United States
    Recruiting
  • St. Jude Children's Research Hospital
    Memphis, Tennessee 38105, United States
    • Seth E. Karol, MD, MSCI · Contact · referralinfo@stjude.org · 888-226-4343
    • Seth E. Karol, MD, MSCI · Principal investigator
    Recruiting
08

References and documents

Publications

  • Davis KL, Yao CC, Zimmerman JAO, Rau RE. Immunotherapy in B-Cell Acute Lymphoblastic Leukemia. J Natl Compr Canc Netw. 2025 Dec;23(12):e257067. doi: 10.6004/jnccn.2025.7067. PubMed 41671463 ↗

Individual participant data

Plan to share: Yes — Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06533748
Lead sponsor
St. Jude Children's Research Hospital
Collaborators
Pfizer, Amgen
Responsible party
Sponsor
First posted
Aug 1, 2024
Start date
Jan 23, 2025
Primary completion
May 2028 (estimated)
Completion
May 2034 (estimated)
Last update
Jul 16, 2026

Study contacts

Seth E. Karol, MD, MSCI
Contact
referralinfo@stjude.org
888-226-4343
Seth Karol, MD, MSCI
principal investigator · St. Jude Children's Research Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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