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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06533748 | Therapy for Newly Diagnosed Patients With B-Cell Precursor Acute Lymphoblastic Leukemia and Lymphoma | PHASE2 | RECRUITING | 128 | — | — | Jan 23, 2025 | May 1, 2034 | May 1, 2026 | 2 | United States |
Flow cytometry (preferred) or next generation sequencing measurement of bone marrow with \<0.01% leukemia with resolution of extramedullary disease at the end of induction (approximately day 29) and will be analyzed within 6 months of the last participant reaching the timepoint.
| Arm | Type | Description |
|---|---|---|
| SJALL23H Treated Patients | EXPERIMENTAL | All eligible patients receive intervention according to the Detailed Description section with the following: Induction: Dexamethasone, Vincristine, Inotuzumab, Blinatumomab, Cyclophosphamide, Dasatinib, IT MHA. Early Post Induction: Cyclophosphamide, Cytarabine, Inotuzumab, Methotrexate, IT MHA, Dasatinib, Blinatumomab, 6-mercaptopurine, Dexamethasone, Vincristine, Daunorubicin, Calaspargase. Maintenance: Dexamethasone, Vincristine, Methotrexate, 6-mercaptopurine, Thioguanine, Dasatinib, IT MHA. |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | Given orally (PO) or intravenously (IV). |
| Vincristine | DRUG | Given IV. |
| Inotuzumab | DRUG | Given IV. |
| Blinatumomab | DRUG | Given IV. |
| Dasatinib | DRUG | Given PO. |
| IT MHA | PROCEDURE | Given Intrathecal (IT), Age adjusted. |
| Cyclophosphamide | DRUG | Given IV. |
| Cytarabine | DRUG | Given IV or IT. |
| Methotrexate | DRUG | Given IT, IV, PO or intramuscular (IM). |
| 6-Mercaptopurine | DRUG | Given PO. |
| Calaspargase | DRUG | Given IV. |
| Daunorubicin | DRUG | Given IV. |
| 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. * B-Acute lymphoblastic leukemia or lymphoblastic lymphoma. * No prior chemotherapy excluding therapy given on or allowed by INITIALL. * NCI high-risk (age 10 years or greater or presenting WBC ...