Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06390319 | 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) | PHASE2 | RECRUITING | 100 | — | — | Dec 27, 2024 | Dec 1, 2033 | May 1, 2026 | 3 | United States |
Comparison of the probability of achieving negative MRD (\<0.01%) and M1 bone marrow status at the end of induction between this protocol and COG AALL1231 will be performed. Statistical analysis of the primary objective will be conducted according to a group sequential design with 1 interim analysis, by a slightly modified version of the procedure for binary endpoint.
The proportion of patients with ETP or near-ETP treated with venetoclax based induction will be compared to the rate of such unsuccessful induction in patients treated on AALL1231 with a standard 4-drug induction. The probability of achieving negative MRD will be tested using a one-sided exact binomial proportion test.
| Arm | Type | Description |
|---|---|---|
| Patients with T-ALL (except ETP or near-ETP) | EXPERIMENTAL | 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 |
| Patients with ETP or near-ETP ALL or MPAL | EXPERIMENTAL | All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, Nelarabine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Venetoclax Maintenance: Mercaptopurine, Methotrexate, Nelarabine, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine |
| Patients with T-LLy | EXPERIMENTAL | All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib, IT MHA Early Post Induction: Cyclophosphamide, Cytarabine, Mercaptopurine, IT MHA, Methotrexate, Dexamethasone, Vincristine, Daunorubicin, Calaspargase pegol, Bortezomib Maintenance: Mercaptopurine, Methotrexate, Cyclophosphamide, Cytarabine, Dexamethasone, Vincristine, IT MHA, Thioguanine |
| Name | Type | Description |
|---|---|---|
| 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). |
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 co...