RecruitingNCT06390319Updated Aug 10, 2026

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 interventional study of Dexamethasone and Vincristine in T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma and Mixed Phenotype Acute Leukemia, sponsored by St. Jude Children's Research Hospital. Recruiting at 4 sites in United States. Open to participants aged 1 Year to 18 Years. Per ClinicalTrials.gov, last updated 2026-08-10.

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

From the registry’s dates

Started Dec 2024; still recruiting 1 year 9 months later.

Phase: Phase 2
Study type: Interventional
Enrollment: 100
Allocation: Non-randomized
Ages: 1 Year to 18 Years
Sex: All

Study 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.

Primary Objective

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.

Conditions studied

T-cell Acute Lymphoblastic Leukemia
T-cell Lymphoma
Mixed Phenotype Acute Leukemia

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Keywords

Newly Diagnosed
Children
Young Adults
T-cell Acute Lymphoblastic Leukemia
T-cell Lymphoma
Mixed Phenotype Acute Leukemia (MPAL)

In context

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

152 studies on the registry are indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; 64 are open to participants now.

This study's planned enrollment of 100 is above the median of 30 across 125 interventional studies indexed under Precursor T-Cell Lymphoblastic Leukemia-Lymphoma.

Browse Precursor T-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.

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.
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
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)

Exclusion criteria

Exclusion Criteria:

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
Patients with T-ALL (except ETP or near-ETP)
All 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
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
Experimental
Patients with ETP or near-ETP ALL or MPAL
All 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
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
Experimental
Patients with T-LLy
All 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
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

Interventions

DrugDexamethasone
Given orally (PO) or intravenously (IV).
Also known as: Decadron, Hexadrol®
DrugVincristine
Given IV.
Also known as: Vincristine Sulfate, Oncovin
DrugDaunorubicin
Given IV.
Also known as: Daunomycin
DrugCalaspargase pegol
Given IV.
Also known as: ASPARLAS
DrugDasatinib
Given PO
Also known as: Sprycel®
DrugVenetoclax
Given PO (ETP, near-ETP, and MPAL only).
Also known as: Venclexta®
DrugBortezomib
Given IV (T-LLy only).
Also known as: Velcade®
DrugIntrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
Given Intrathecal (IT), Age adjusted.
Also known as: IT MHA
DrugCyclophosphamide
Given IV.
Also known as: Cytoxan®
DrugCytarabine
Given IV or IT.
Also known as: Ara-C, Cytosine arabinoside
DrugMercaptopurine
Given PO.
Also known as: 6-MP
DrugNelarabine
Given IV
Also known as: Arranon, Atriance
DrugMethotrexate
Given IT, IV, PO or intramuscular (IM).
Also known as: Trexall®
DrugThioguanine
Given PO (participants intolerant to mercaptopurine).
Also known as: 6-thioguanine, Tabloid®

What researchers measure

Primary outcomes

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.
Time frame: Up to end of induction day 29 or death
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.
Time frame: Up to end of induction day 29 or death

Secondary outcomes

Event-free survival (EFS)
Kaplan-Meier estimates for EFS will be calculated along with standard error.
Time frame: Up to 10 years
Overall survival (OS)
Kaplan-Meier estimates for OS will be calculated along with standard error.
Time frame: Up to 10 years
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.
Time frame: Up to 30 days after last dose of study treatment
EFS compared to Total 17 (TOT17-NCT03117751)
Comparisons of EFS to the corresponding TOT17 will be performed by the log-rank test.
Time frame: Up to 10 years
OS compared to TOT17
Comparisons of OS to the corresponding TOT17 will be performed by the log-rank test.
Time frame: Up to 10 years

Study locations

4 of 4 sites recruiting

Rady Children's Hospital
San Diego, California 92123, United States
- Victor Wong, MD · Contact · vwong@rchsd.org · 858-966-5811
- Victor Wong, MD · Principal investigator
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
- Ashraf Mohamed, MD · Contact · ammohamed@saintfrancis.com · 918-502-6720
- Ashraf Mohamed, MD · Principal investigator
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

References and documents

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 ↗

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

Updates

Tracking since Sep 25, 2026

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

Registry details

Key details

Study ID: NCT06390319
Lead sponsor: St. Jude Children's Research Hospital
Collaborators: AbbVie
Responsible party: Sponsor
First posted: Apr 30, 2024
Start date: Dec 27, 2024
Primary completion: Dec 2027 (estimated)
Completion: Dec 2033 (estimated)
Last update: Aug 10, 2026

Study contacts

Seth E. Karol, MD, MSCI

Contact

referralinfo@stjude.org

888-226-4343

Seth E. 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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