NCT06390319RecruitingPhase 2
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)
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)
Source: ClinicalTrials.gov · Last updated 10 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 25 Apr 2024
- Start date
- 27 Dec 2024
- Primary completion date
- Dec 2027
- Lead sponsor
- St. Jude Children's Research Hospital
- NCT number
- NCT06390319
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 27 Dec 2024 to the primary completion date, Dec 2027
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- For patients of reproductive potential, unwillingness to use highly effective contraception for the duration of protocol therapy and for 90 days afterwards.
- Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days of the start of protocol therapy.
Other illness
- 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).
Other
- 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).
- Pregnant or lactating.
- 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.
Who the study is looking for
- 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)
Age in the registry: 1 year to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Novant Health Presbyterian Hemby Children's Hospital Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| St. Jude Children's Research Hospital Coordinator of this site? Confirm its status | Memphis | United States | Recruiting |
| Rady Children's Hospital Coordinator of this site? Confirm its status | San Diego | United States | Recruiting |
| Saint Francis Children's Hospital Coordinator of this site? Confirm its status | Tulsa | United States | Recruiting |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.