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AzTrials

T-cell Acute Lymphoblastic LeukemiaPhase 2NCT06390319

Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

A Phase 2 study testing Dexamethasone, Vincristine and Daunorubicin in people with T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoma, run by St. Jude Children's Research Hospital at 4 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
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Trial summary

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia. Read more about this study

Who is it for?
Ages 1 year to 18 years
What is being tested?
Dexamethasone, Vincristine and Daunorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
4 sitesUnited States
Study dates
27 Dec 2024to Dec 2033
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.
  • T-Acute lymphoblastic leukemia or lymphoblastic lymphoma or mixed phenotype acute leukemia/ lymphoma
  • No prior chemotherapy excluding therapy given on or allowed by INITIALL.
  • Patient has completed no more than 3 days of chemotherapy on INITIALL.
  • Direct bilirubin ≤ 1.5x the upper limit of normal for age
Show all 14Show fewer
  • Alanine aminotransferase (ALT) ≤ 5x the upper limit of normal for age
  • 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), 0.6 (Female)
  • Age: 2 to < 6 years - Maximum serum creatinine (mg/dL): 0.8 (Male), 0.8 (Female)
  • Age: 6 to < 10 years - Maximum serum creatinine (mg/dL): 1 (Male), 1 (Female)
  • Age: 10 to < 13 years - Maximum serum creatinine (mg/dL): 1.2 (Male), 1.2 (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)

Who cannot join

  • Inability or unwillingness to give informed consent/ assent as applicable.
  • Patients with > Grade 2 neuropathy at the time of enrollment (participant with T-LLy only).
  • Documented malabsorption syndrome or any other condition that precludes receipt of oral medications.
  • Known HIV infection or active hepatitis B (defined as hepatitis B surface antigen-positive) or C (defined as hepatitis C antibody-positive).
  • Pregnant or lactating.
  • For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.
  • Receipt of a strong or moderate CYP3A4 inducer such as rifampin, carbamazepine, phenytoin, and St. John's wort within 7 days of the start of protocol treatment.
  • Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.

Trial locations and contacts

4 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 States4 sites, 4 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

  • Rady Children's Hospital

    San Diego, California, 92123

    Victor Wong, MD, 858-966-5811, vwong@rchsd.org

    Victor Wong, MD

    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: SJALL23T: Adding Dasatinib Or Venetoclax To Improve Responses In Children With Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia (ALL) Or Lymphoma (T-LLY) Or Mixed Phenotype Acute Leukemia (MPAL)

This is a clinical trial testing whether the addition of one of two chemotherapy agents, dasatinib or venetoclax, can improve outcomes for children and young adults with newly diagnosed T-cell acute lymphoblastic leukemia and lymphoma or mixed phenotype acute leukemia.

Primary Objective

Read more
  • To evaluate if the end of induction MRD-negative rate is higher in patients with T-ALL treated with dasatinib compared to similar patients treated with 4-drug induction on AALL1231.
  • To evaluate if the end of induction MRD-negative rate is higher in patients with ETP or near-ETP ALL treated with venetoclax compared to similar patients treated with 4-drug induction on AALL1231.

Secondary Objectives

  • To assess the event free and overall survival of patients treated with this therapy.
  • To compare grade 4 toxicities, event-free survival (EFS) and overall survival (OS) of patients treated with this therapy in induction and reinduction to toxicities of similar patients treated on TOT17.
Read the detailed description

Patients will be identified in the first 3 days of therapy during their treatment on INITIALL.

Treatment will consist of 3 main phases: Induction, Early Post Induction [including Consolidation, High-Dose Methotrexate, Intensification, Interim 1, Reinduction 1, Interim 2, and Reinduction 2], and Maintenance.

Induction:

  • Remission Induction includes 3 days of therapy on the INITIALL classification protocol as well as the remainder of a total of 4 weeks of induction treatment on this trial. Treatment includes a total of 28 days of dexamethasone, 4 weekly doses of vincristine, 3 doses of daunorubicin, 1 dose of Calaspargase pegol, 6 doses of Intrathecal triple therapy (IT MHA), and one of 3 additional drugs. Patients with T-ALL without near-ETP or ETP phenotype (hereafter referred to simply as T-ALL) will receive 25 days of dasatinib. Patients with ETP or near-ETP ALL as well as those with MPAL will receive 14 days of venetoclax. Patients with T-LLy will receive bortezomib. 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.

Early Post Induction:

  • Consolidation will be given following completion of Remission Induction Therapy. Patients will receive 2 cycles of BFM-1b therapy (a single dose of cyclophosphamide at the start of week 1, 4 daily doses of cytarabine in two consecutive weeks, and 2 weeks of mercaptopurine) separated by a week of nelarabine. Patients will have a week without chemotherapy at the end of Consolidation.
  • High-dose Methotrexate will be given for 4 cycles to all patients. Patients will also receive an intrathecal chemotherapy treatment with each of the 2-week cycles and will take oral mercaptopurine continuously if tolerated.
  • Intensification will be given to patients with T-ALL or ETP/ near-ETP. This therapy includes a week of nelarabine, one week of combination cyclophosphamide and cytarabine, and 1 week of rest without chemotherapy.
  • Interim Therapy 1 includes 6 weeks of oral mercaptopurine, 2 weeks (5 days of each week) of dexamethasone, and two doses (weeks 1 and 4) of daunorubicin, vincristine, and calaspargase pegol.
  • Reinduction Therapy 1 will consist of 3 weekly doses of vincristine, 1 dose of daunorubicin and calaspargase pegol at the start of the first week, and dexamethasone for 7 days in the first and third weeks. Patients will also receive the same additional agent received during induction based on immunophenotype.
  • Interim Therapy 2 includes 6 weeks of oral mercaptopurine, two doses (weeks 1 and 4) of daunorubicin, vincristine, and calaspargase pegol.
  • Reinduction Therapy 2 will consist of 3 weekly doses of vincristine, 1 dose of daunorubicin and calaspargase pegol at the start of the first week, and dexamethasone for 7 days in the first and third weeks. Patients will also receive the same additional agent received during induction based on immunophenotype.

Maintenance therapy:

  • Early Maintenance Therapy follows Reinduction 2 and lasts 31 weeks. Patients will receive mercaptopurine and methotrexate interrupted by 1 week of nelarabine (week 3), 5 cyclophosphamide/ cytarabine pulses, and every 4-week dexamethasone/ vincristine pulses. For the first 32 weeks, patients will also receive every 4-week pulses including 5 days of dexamethasone and 1 dose of vincristine. Patients will receive low-dose methotrexate in all weeks when they do not receive dexamethasone or vincristine. All patients will receive every 4-week intrathecal chemotherapy beginning 4 weeks after the week of nelarabine.
  • Late Maintenance Therapy follows early maintenance and includes daily mercaptopurine, weekly methotrexate, and every 8-week intrathecal chemotherapy. It lasts a total of 44 weeks.

Duration of therapy is approximately 2¼ years. It is recommended that patients be followed every 4 months for 1 year, every 6 months for 1 year and then yearly until the patient is in remission for 10 years and is at least 18 years old.

Being tested
Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib
Keywords
Newly Diagnosed, Children, Young Adults, T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma, Mixed Phenotype Acute Leukemia (MPAL)
Medical subject headings
Precursor T-Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, T-Cell, Leukemia, Biphenotypic, Acute

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.

  • DaunorubicinDrug

    Also called Daunomycin

    Given IV.

  • Calaspargase pegolDrug

    Also called ASPARLAS

    Given IV.

  • DasatinibDrug

    Also called Sprycel®

    Given PO

  • VenetoclaxDrug

    Also called Venclexta®

    Given PO (ETP, near-ETP, and MPAL only).

  • BortezomibDrug

    Also called Velcade®

    Given IV (T-LLy only).

  • Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)Drug

    Also called IT MHA

    Given Intrathecal (IT), Age adjusted.

  • CyclophosphamideDrug

    Also called Cytoxan®

    Given IV.

  • CytarabineDrug

    Also called Ara-C, Cytosine arabinoside

    Given IV or IT.

  • MercaptopurineDrug

    Also called 6-MP

    Given PO.

  • NelarabineDrug

    Also called Arranon, Atriance

    Given IV

  • MethotrexateDrug

    Also called Trexall®

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

  • ThioguanineDrug

    Also called 6-thioguanine, Tabloid®

    Given PO (participants intolerant to mercaptopurine).

Study groups in NCT06390319
Study groupRoleWhat they receive
Patients with T-ALL (except ETP or near-ETP)ExperimentalAll eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dasatinib, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, Dasatinib, IT MHA, Thioguanine
Receives: Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Calaspargase pegol; Drug: Dasatinib; Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine); Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Nelarabine; Drug: Methotrexate; Drug: Thioguanine
Patients with ETP or near-ETP ALL or MPALExperimentalAll eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine
Receives: Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Calaspargase pegol; Drug: Venetoclax; Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine); Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Nelarabine; Drug: Methotrexate; Drug: Thioguanine
Patients with T-LLyExperimentalAll eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib Maintenance: Mercaptopurine, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine
Receives: Drug: Dexamethasone; Drug: Vincristine; Drug: Daunorubicin; Drug: Calaspargase pegol; Drug: Bortezomib; Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine); Drug: Cyclophosphamide; Drug: Cytarabine; Drug: Mercaptopurine; Drug: Methotrexate; Drug: Thioguanine

What is being measured

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

  1. Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia

    Comparison of the probability of achieving negative MRD (<0.01%) and M1 bone marrow status at the end of induction between this protocol and COG AALL1231 will be performed. Statistical analysis of the primary objective will be conducted according to a group sequential design with 1 interim analysis, by a slightly modified version of the procedure for binary endpoint.

    Measured: Up to end of induction day 29 or death

  2. MRD-negativity rate in patients with ETP or near ETP ALL

    The proportion of patients with ETP or near-ETP treated with venetoclax based induction will be compared to the rate of such unsuccessful induction in patients treated on AALL1231 with a standard 4-drug induction. The probability of achieving negative MRD will be tested using a one-sided exact binomial proportion test.

    Measured: Up to end of induction day 29 or death

Secondary outcomes (5)

  1. Event-free survival (EFS)

    Kaplan-Meier estimates for EFS will be calculated along with standard error.

    Measured: Up to 10 years

  2. Overall survival (OS)

    Kaplan-Meier estimates for OS will be calculated along with standard error.

    Measured: Up to 10 years

  3. Incidence of grade 4 toxicities

    Adverse events will be graded using Common Terminology Criteria for Adverse Events version 5 and compared using Fisher's or exact Chi-square test.

    Measured: Up to 30 days after last dose of study treatment

  4. EFS compared to Total 17 (TOT17-NCT03117751)

    Comparisons of EFS to the corresponding TOT17 will be performed by the log-rank test.

    Measured: Up to 10 years

  5. OS compared to TOT17

    Comparisons of OS to the corresponding TOT17 will be performed by the log-rank test.

    Measured: Up to 10 years

Timeline

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

  1. First posted30 Apr 2024
  2. Study start27 Dec 2024
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2033 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06390319
Sponsor's protocol ID
SJALL23T
Other IDs
NCI-2024-03015
Status last verified
Aug 2026
First submitted
25 Apr 2024
Last updated
10 Aug 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

  • Hu H, Zhao H, Lu P, Ma T, Yoshimura S, Karol SE, Pui CH, Teachey DT, Yang JJ, Ng AHC, Lu Y. muPharma: A microfluidic, AI-driven pharmacotyping platform for single-cell drug sensitivity prediction in leukemia. Med. 2026 Mar 13;7(3):100966. doi: 10.1016/j.medj.2025.100966. Epub 2026 Jan 30.

    PubMed 41619724

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexamethasone, Vincristine and Daunorubicin in people with T-cell Acute Lymphoblastic Leukemia and T-cell Lymphoma, run by St. Jude Children's Research Hospital at 4 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 14 inclusion and 8 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 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia (time frame: Up to end of induction day 29 or death). The study lists 2 primary outcomes in all. 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 NCT06390319, 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 10 Aug 2026.

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