Recruiting
Phase 2

Dasatinib & Venetoclax

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT06390319

Conditions

T-cell Acute Lymphoblastic Leukemia

T-cell Lymphoma

Mixed Phenotype Acute Leukemia

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

Interventions

Dexamethasone

Vincristine

Daunorubicin

Calaspargase pegol

Dasatinib

Study Details

Brief 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.

Conditions

T-cell Acute Lymphoblastic Leukemia

T-cell Lymphoma

Mixed Phenotype Acute Leukemia

Study ID

NCT06390319

Start date

Dec 27, 2024

Status verified date

Aug, 2026

Completion date

Dec, 2033

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 18

Healthy Volunteers: Not accepted

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:

  • 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

Enrollment

100 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

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

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

Interventions

Dexamethasone

Given orally (PO) or intravenously (IV).

Vincristine

Given IV.

Daunorubicin

Given IV.

Calaspargase pegol

Given IV.

Dasatinib

Given PO

Venetoclax

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

Bortezomib

Given IV (T-LLy only).

Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)

Given Intrathecal (IT), Age adjusted.

Cyclophosphamide

Given IV.

Cytarabine

Given IV or IT.

Mercaptopurine

Given PO.

Nelarabine

Given IV

Methotrexate

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

Thioguanine

Given PO (participants intolerant to mercaptopurine).

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 ]
  • MRD-negativity rate in patients with ETP or near ETP ALL [ Time Frame: Up to end of induction day 29 or death ]

Central Contacts and Locations

Central contacts

Seth E. Karol, MD, MSCI

888-226-4343referralinfo@stjude.org

Locations

Rady Children's Hospital

Recruiting

San Diego, California, United States, 92123

Contacts

Victor Wong, MD

858-966-5811vwong@rchsd.org

Principal Investigator:

Victor Wong, MD

Novant Health Presbyterian Hemby Children's Hospital

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Jessica Bell, MD

704-384-1900jbell@novanthealth.org

Principal Investigator:

Jessica Bell, MD

Saint Francis Children's Hospital

Recruiting

Tulsa, Oklahoma, United States, 74136

Contacts

Ashraf Mohamed, MD

918-502-6720ammohamed@saintfrancis.com

Principal Investigator:

Ashraf Mohamed, MD

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Seth E. Karol, MD, MSCI

888-226-4343referralinfo@stjude.org

Principal Investigator:

Seth E. Karol, MD, MSCI

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-10.