Actively Recruiting
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)
Led by St. Jude Children's Research Hospital · Updated on 2026-05-01
100
Participants Needed
3
Research Sites
465 weeks
Total Duration
On this page
Sponsors
S
St. Jude Children's Research Hospital
Lead Sponsor
A
AbbVie
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Enrollment on INITIALL.
- Age 1 to 18.99 years at enrollment.
- Diagnosis of T-acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia/lymphoma.
- No prior chemotherapy except as allowed by INITIALL.
- Completed no more than 3 days of chemotherapy on INITIALL.
- Direct bilirubin less than or equal to 1.5 times the upper limit of normal for age.
- Alanine aminotransferase (ALT) less than or equal to 5 times the upper limit of normal for age.
- Calculated glomerular filtration rate (GFR) at least 50 mL/min/1.73m2 or serum creatinine below age- and gender-specific maximum levels.
You will not qualify if you...
- Inability or unwillingness to give informed consent or assent.
- Patients with greater than Grade 2 neuropathy at enrollment (for T-LLy patients only).
- Documented malabsorption syndrome or any condition preventing oral medication intake.
- Known HIV infection or active hepatitis B or C infection.
- Pregnant or breastfeeding.
- Unwillingness to use highly effective contraception during treatment and for 90 days after.
- Use of strong or moderate CYP3A4 inducers within 7 days before starting treatment.
- Consumption of grapefruit, grapefruit products, Seville oranges, or starfruit within 3 days before starting treatment.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Rady Children's Hospital
San Diego, California, United States, 92123
Actively Recruiting
2
Saint Francis Children's Hospital
Tulsa, Oklahoma, United States, 74136
Actively Recruiting
3
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Actively Recruiting
Research Team
S
Seth E. Karol, MD, MSCI
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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