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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05848687 | TINI 2: Total Therapy for Infants With Acute Lymphoblastic Leukemia II | PHASE1 | RECRUITING | 90 | — | — | Nov 3, 2023 | Dec 1, 2033 | Jun 3, 2026 | 24 | United States, Canada |
Proportion of patients who are minimal residual disease positive at the end of Induction Intensification
| Arm | Type | Description |
|---|---|---|
| Treatment | EXPERIMENTAL | Participants who meet eligibility criteria will receive remission induction, induction intensification, consolidation I, reinduction block I, reinduction block II, consolidation II, and Maintenance. Interventions: Dexamethasone, Mitoxantrone, PEG-asparaginase, Bortezomib, Vorinostat, Mercaptopurine, Methotrexate and Vincristine, Blinatumomab, Ziftomenib |
| Name | Type | Description |
|---|---|---|
| Dexamethasone | DRUG | Given orally (PO) or naso-gastrically (NG) or intravenously (IV). |
| Mitoxantrone | DRUG | Given IV |
| PEG asparaginase | DRUG | Given IV |
| Bortezomib | DRUG | Given IV |
| Vorinostat | DRUG | Taken PO or NG |
| Mercaptopurine | DRUG | Given PO or NG. |
| Methotrexate | DRUG | Given IV, IM or PO |
| Blinatumomab | DRUG | Will be administered at 15 mcg/m2/day for 28 days following induction and reinduction |
| Ziftomenib | DRUG | 3+3 dose escalation will be done. Dose level 1 will start at 75% of the adult recommended phase two dosing which has been established in phase I studies. Based on tolerability, we will either de-escalate to 50% RP2D (dose level -1) or escalate to 100% RP2D |
Inclusion Criteria: * Patient is ≤ 365 days of age at the time of diagnosis. * Patient has newly diagnosed CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia. Subjects with bilineage or biphenotypic acute leukemia are eligible provided they express CD19. Patients wi...