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)

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age1 Year to 18 Years
• SexAll
• Healthy volunteersNo

You may be able to join 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 cannot join 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.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

dasatinib. An orally bioavailable synthetic small molecule-inhibitor of SRC-family protein-tyrosine kinases. Dasatinib binds to and inhibits the growth-promoting activities of these kinases. Apparently because of its less stringent binding affinity for the BCR-ABL kinase, dasatinib has been shown to overcome the resistance to imatinib of chronic myeloid leukemia (CML) cells harboring BCR-ABL kinase domain point mutations. SRC-family protein-tyrosine kinases interact with a variety of cell-surface receptors and participate in intracellular signal transduction pathways; tumorigenic forms can occur through altered regulation or expression of the endogenous protein and by way of virally-encoded kinase genes. NCI Drug Dictionary

venetoclax. An orally bioavailable, selective small molecule inhibitor of the anti-apoptotic protein Bcl-2, with potential antineoplastic activity. Venetoclax mimics BH3-only proteins, the native ligands of Bcl-2 and apoptosis activators, by binding to the hydrophobic groove of Bcl-2 proteins thereby repressing Bcl-2 activity and restoring apoptotic processes in tumor cells. Bcl-2 protein is overexpressed in some cancers and plays an important role in the regulation of apoptosis; its expression is associated with increased drug resistance and tumor cell survival. Compared to the Bcl-2 inhibitor navitoclax, this agent does not inhibit bcl-XL and does not cause bcl-XL-mediated thrombocytopenia. NCI Drug Dictionary

bortezomib. A dipeptide boronic acid analogue with antineoplastic activity. Bortezomib reversibly inhibits the 26S proteasome, a large protease complex that degrades ubiquinated proteins. By blocking the targeted proteolysis normally performed by the proteasome, bortezomib disrupts various cell signaling pathways, leading to cell cycle arrest, apoptosis, and inhibition of angiogenesis. Specifically, the agent inhibits nuclear factor (NF)-kappaB, a protein that is constitutively activated in some cancers, thereby interfering with NF-kappaB-mediated cell survival, tumor growth, and angiogenesis. In vivo, bortezomib delays tumor growth and enhances the cytotoxic effects of radiation and chemotherapy. NCI Drug Dictionary

Treatments listed in the registry

• Dexamethasone (Drug): Given orally (PO) or intravenously (IV).
• Vincristine (Drug): Given IV.
• Daunorubicin (Drug): Given IV.
• Calaspargase pegol (Drug): Given IV.
• Dasatinib (Drug): Given PO
• Venetoclax (Drug): Given PO (ETP, near-ETP, and MPAL only).
• Bortezomib (Drug): Given IV (T-LLy only).
• Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) (Drug): Given Intrathecal (IT), Age adjusted.
• Cyclophosphamide (Drug): Given IV.
• Cytarabine (Drug): Given IV or IT.
• Mercaptopurine (Drug): Given PO.
• Nelarabine (Drug): Given IV
• Methotrexate (Drug): Given IT, IV, PO or intramuscular (IM).
• Thioguanine (Drug): Given PO (participants intolerant to mercaptopurine).

Non Randomized · Parallel · masking: None

Main goals

• Minimal residual disease (MRD)-negativity rate in patients with T cell acute lymphoblastic leukemia (Up to end of induction day 29 or death)
• MRD-negativity rate in patients with ETP or near ETP ALL (Up to end of induction day 29 or death)

Other goals

• Event-free survival (EFS)
• Overall survival (OS)
• Incidence of grade 4 toxicities
• EFS compared to Total 17 (TOT17-NCT03117751)
• OS compared to TOT17

Planned enrollment: 100 (estimated).

• Rady Children's Hospital, San Diego, California
• Novant Health Presbyterian Hemby Children's Hospital, Charlotte, North Carolina
• Saint Francis Children's Hospital, Tulsa, Oklahoma
• St. Jude Children's Research Hospital, Memphis, Tennessee

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Linked by the registry; not confirmed as results from this trialHu H, Zhao H, Lu P, Ma T, Yoshimura S, Karol SE, Pui CH, Teachey DT, Yang JJ, Ng AHC, Lu Y. muPharma: A microfluidic, AI-driven pharmacotyping platform for single-cell drug sensitivity prediction in leukemia. Med. 2026 Mar 13;7(3):100966. doi: 10.1016/j.medj.2025.100966. Epub 2026 Jan 30.

• ClinicalTrials.gov NCT06390319
• NCI Drug Dictionary: C38713
• NCI Drug Dictionary: C103147
• NCI Drug Dictionary: C1851

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Aug 9, 2026. Public record; not medical advice.