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)
| NCT ID | NCT06390319 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | T-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-12-27 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-12-27 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Seth E. Karol, MD, MSCI
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT06390319 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 18 Years, studying T-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06390319 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06390319 currently recruiting?
Yes, NCT06390319 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT06390319 trial being conducted?
This trial is being conducted at San Diego, United States, Charlotte, United States, Tulsa, United States, Memphis, United States.
Who is sponsoring the NCT06390319 clinical trial?
NCT06390319 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Seth E. Karol, MD, MSCI at St. Jude Children's Research Hospital. The trial plans to enroll 100 participants.
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