Actively Recruiting
Adding Dasatinib or Venetoclax to Improve Responses in Children with Newly Diagnosed T-Cell Acute Lymphoblastic Leukemia, Lymphoma, or Mixed Phenotype Acute Leukemia
Led by St. Jude Children's Research Hospital · Updated on 2026-05-01
100
Participants Needed
3
Research Sites
313 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
Researchers are evaluating whether adding one of two chemotherapy drugs, dasatinib or venetoclax, can improve treatment outcomes for children and young adults newly diagnosed with T-cell acute lymphoblastic leukemia, lymphoma, or mixed phenotype acute leukemia. The study aims to compare the rate of minimal residual disease negativity at the end of induction therapy between patients receiving these drugs and those treated with a standard 4-drug induction. Secondary goals include assessing event-free and overall survival as well as comparing treatment toxicities to previous studies. Treatment involves three main phases: Induction, Early Post Induction, and Maintenance, lasting about two and a quarter years. During Induction, patients receive a combination of chemotherapy drugs including dexamethasone, vincristine, daunorubicin, calaspargase pegol, and one additional drug based on their leukemia type—dasatinib for typical T-ALL, venetoclax for ETP or near-ETP ALL and MPAL, or bortezomib for T-LLy. Early Post Induction includes cycles of consolidation therapy with various drugs, high-dose methotrexate, intensification for certain patients, interim therapies, and reinduction therapies. Maintenance therapy follows, involving multiple chemotherapy drugs given in cycles over about 75 weeks. Participants will be monitored through regular assessments including minimal residual disease testing at the end of induction, survival tracking for up to 10 years, and evaluation of treatment-related toxicities. Follow-up visits are recommended every 4 months for one year, then every 6 months for another year, and annually thereafter until remission lasts 10 years and the participant reaches 18 years of age. The study is non-randomized and open-label, with all eligible patients receiving treatment based on their leukemia subtype.
CONDITIONS
Brief 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 protocol
- Age between 1 and 18.99 years at enrollment
- Diagnosis of T-cell acute lymphoblastic leukemia, lymphoblastic lymphoma, or mixed phenotype acute leukemia/lymphoma
- No prior chemotherapy except what is allowed by INITIALL
- Completed no more than 3 days of chemotherapy on INITIALL
- Direct bilirubin level less than or equal to 1.5 times the upper normal limit for age
- Alanine aminotransferase (ALT) level less than or equal to 5 times the upper normal limit for age
- Kidney function with calculated glomerular filtration rate (GFR) of at least 50 mL/min/1.73m2 or creatinine within specified age- and sex-based limits
You will not qualify if you...
- Unable or unwilling 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 use
- Known HIV infection or active hepatitis B or C infection
- Pregnant or breastfeeding
- Unwillingness to use 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, Seville oranges, or starfruit within 3 days before starting treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 4 weeks
Participants receive remission induction therapy including dexamethasone, vincristine, daunorubicin, calaspargase pegol, intrathecal triple therapy, and one additional drug based on leukemia subtype. This phase includes 28 days of treatment followed by a week without chemotherapy.
Weekly visits during induction treatment
Duration - Several months covering multiple cycles
Participants undergo consolidation, high-dose methotrexate, intensification (for some), interim therapies, and reinduction therapies with various drug combinations based on leukemia subtype. This phase includes multiple cycles separated by rest weeks.
Multiple visits corresponding to treatment cycles and assessments
Duration - Approximately 75 weeks
Participants receive early and late maintenance therapy involving mercaptopurine, methotrexate, nelarabine, cyclophosphamide, cytarabine, dexamethasone, vincristine, and intrathecal chemotherapy over approximately 1.5 years.
Visits every 4 weeks during early maintenance and every 8 weeks during late maintenance
Duration - Up to 10 years
Participants are followed regularly after therapy completion to monitor remission status and overall health.
Visits every 4 months for 1 year, then every 6 months for 1 year, then yearly
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
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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