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 now · Phase 2
Conditions studied: T-cell Acute Lymphoblastic Leukemia, T-cell Lymphoma, Mixed Phenotype Acute Leukemia
In brief
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.
Key facts
- Study ID
- NCT06390319
- Run by
- St. Jude Children's Research Hospital
- People needed
- 100
- Starts
- 2024-12-27
- Expected to finish
- 2033-12-01
- Last updated by the study team
- 2026-07-16
Who can join
Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- Rady Children's Hospital — San Diego, California, United States (enrolling)
- Novant Health Presbyterian Hemby Children's Hospital — Charlotte, North Carolina, United States (enrolling)
- Saint Francis Children's Hospital — Tulsa, Oklahoma, United States (enrolling)
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (enrolling)
Full record on ClinicalTrials.gov
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