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Acute Lymphoblastic LeukemiaPhase 2NCT06533748

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

A Phase 2 study testing Dexamethasone, Vincristine and Inotuzumab in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by St. Jude Children's Research Hospital at 3 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 1 year to 18 years
What is being tested?
Dexamethasone, Vincristine and Inotuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
3 sitesUnited States
Study dates
23 Jan 2025to May 2034
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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)
Show all 26Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Seth E. Karol, MD, MSCI contact

888-226-4343

referralinfo@stjude.org

United States3 sites, 3 recruiting

  • Novant Health Presbyterian Hemby Children's Hospital

    Charlotte, North Carolina, 28204

    Jessica Bell, MD, 704-384-1900, jbell@novanthealth.org

    Jessica Bell, MD

    Recruiting

  • St. Jude Children's Research Hospital

    Memphis, Tennessee, 38105

    Seth E. Karol, MD, MSCI, 888-226-4343, referralinfo@stjude.org

    Seth E. Karol, MD, MSCI

    Recruiting

  • Saint Francis Children's Hospital

    Tulsa, Oklahoma, 74136

    Ashraf Mohamed, MD, 918-502-6720, ammohamed@saintfrancis.com

    Ashraf Mohamed, MD

    Recruiting

Other trials in United States

About this study

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

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

Read more
  • 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.

Being tested
Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Dasatinib
Keywords
Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Newly Diagnosed, Antigen-directed therapies, Induction therapy, Children, Young Adults
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DexamethasoneDrug

    Also called Decadron, Hexadrol®

    Given orally (PO) or intravenously (IV).

  • VincristineDrug

    Also called Vincristine Sulfate, Oncovin

    Given IV.

  • InotuzumabDrug

    Also called Inotuzumab ozogamicin, BESPONSA®

    Given IV.

  • BlinatumomabDrug

    Also called BLINCYTO®

    Given IV.

  • DasatinibDrug

    Also called Sprycel®

    Given PO.

  • IT MHAProcedure or surgery

    Also called Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

    Given Intrathecal (IT), Age adjusted.

  • CyclophosphamideDrug

    Also called Cytoxan®

    Given IV.

  • CytarabineDrug

    Also called Cytosine arabinoside, Ara-C

    Given IV or IT.

  • MethotrexateDrug

    Also called MTX, Trexall®

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

  • 6-MercaptopurineDrug

    Also called Mercaptopurine, 6-MP

    Given PO.

  • CalaspargaseDrug

    Also called ASPARLAS

    Given IV.

  • DaunorubicinDrug

    Also called Daunomycin

    Given IV.

  • ThioguanineDrug

    Also called 6-thioguanine, Tabloid®

    Given PO (participants intolerant to mercaptopurine).

Study groups in NCT06533748
Study groupRoleWhat they receive
SJALL23H Treated PatientsExperimentalAll 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.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: On treatment to end of induction, approximately 29 days

Secondary outcomes (4)

  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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 3.5 years after enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2024
  2. Study start23 Jan 2025
  3. Primary completionMay 2028 (estimated)
  4. Study completionMay 2034 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This study utilizes a single arm phase II design enrolling eligible participants with newly diagnosed B-cell precursor acute lymphoblastic leukemia and lymphoma.
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06533748
Sponsor's protocol ID
SJALL23H
Other IDs
NCI-2024-06013
Status last verified
Jul 2026
First submitted
30 Jul 2024
Last updated
16 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Vincristine and Inotuzumab in people with Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma, run by St. Jude Children's Research Hospital at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 26 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Seth E. Karol, MD, MSCI (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

End of induction minimal residual disease negative remission (time frame: On treatment to end of induction, approximately 29 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06533748, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2026.

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