Clinical trial · Interventional
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)
SJALL23T: 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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Mixed Phenotype Acute Leukemia | Mixed Phenotype Acute Leukemia | ONTOLOGY_EXACT | 0.98 |
| T-cell Acute Lymphoblastic Leukemia | T Acute Lymphoblastic Leukemia | CURATED_BROADER | 0.80 |
| T-cell Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (14)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bortezomib | Drug | Bortezomib | ALIAS |
| Calaspargase pegol | Drug | Calaspargase Pegol | ALIAS |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Dasatinib | Drug | Dasatinib | ALIAS |
| Daunorubicin | Drug | Daunorubicin | ALIAS |
| Dexamethasone | Drug | Dexamethasone | ALIAS |
| Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine) | Drug | — |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Patients with T-ALL (except ETP or near-ETP)
- description
- All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Dasatinib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dasatinib, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, Dasatinib, IT MHA, Thioguanine
- interventionNames
- Drug: Dexamethasone
- Drug: Vincristine
- Drug: Daunorubicin
- Drug: Calaspargase pegol
- Drug: Dasatinib
- Drug: Intrathecal triple therapy (methotrexate + hydrocortisone + cytarabine)
- Drug: Cyclophosphamide
- Drug: Cytarabine
- Drug: Mercaptopurine
- Drug: Nelarabine
- Drug: Methotrexate
- Drug: Thioguanine
- type
- EXPERIMENTAL
- label
- Patients with ETP or near-ETP ALL or MPAL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Year
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDHu 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. PMID 41619724