Back to search results

Adding Dasatinib or Venetoclax for Childhood T-cell Leukemia or Lymphoma

This study is looking at whether adding dasatinib or venetoclax to standard chemotherapy can improve outcomes for children and young adults (ages 1 to 18) with newly diagnosed T-cell acute lymphoblastic leukemia (ALL), T-cell lymphoma (T-LLY), or mixed phenotype acute leukemia (MPAL). You would receive standard chemotherapy drugs like dexamethasone, vincristine, daunorubicin, and calaspargase pegol. Depending on your specific type of leukemia, you would also receive either dasatinib (a pill) or venetoclax (a drug given intravenously). The main goal is to see if more patients achieve "minimal residual disease (MRD)-negativity" (meaning very few cancer cells remain) after the first phase of treatment.

Study design
This is an interventional study with a planned enrollment of 100 participants. It aims to compare the effectiveness of adding dasatinib or venetoclax to standard treatment.
What's involved
You would be identified within the first 3 days of therapy on another protocol (INITIALL). Treatment involves three main phases: Induction, Early Post Induction (including several cycles of therapy), and Maintenance.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes, such as MRD-negativity, are measured up to the end of induction (day 29) or death. Event-free and overall survival will also be assessed.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06390319

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)

Recruiting
PHASE2Ages 1–18InterventionalTreatment
St. Jude Children's Research Hospital
~100 participants
Updated 2026-08-10 on ClinicalTrials.gov
What's tested:DexamethasoneVincristineDaunorubicinCalaspargase pegolDasatinibVenetoclax

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia
Measured over Up to end of induction day 29 or death
+1 more outcome measured

Conditions

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

Explore related trials

Mixed Phenotype Acute LeukemiaPre T-ALLT-Cell Non-Hodgkin Lymphoma

Where it's being run

4 sites across 4 states
California1
North Carolina1
Oklahoma1
Tennessee1

Study leadership

  • Seth E. Karol, MD, MSCI · PRINCIPAL_INVESTIGATOR · St. Jude Children's Research Hospital

Who to contact

Seth E. Karol, MD, MSCI
[email protected]
888-226-4343
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemiaUp to end of induction day 29 or death

    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.

  • MRD-negativity rate in patients with ETP or near ETP ALLUp to end of induction day 29 or death

    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.