Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PEG asparaginase · 1 trial · 1 indication
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...
PEG asparaginase is used for Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Leukemia. It is being studied in combination with induction chemotherapy in children with relapsed or refractory ALL, and in total therapy for infants with ALL.
PEG asparaginase is developed by Amgen Inc., a biopharmaceutical company traded on NASDAQ under the ticker AMGN.
PEG asparaginase is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Two Phase 1 trials are listed, one completed and one recruiting.
PEG asparaginase is associated with two clinical trials. NCT02303821, a completed Phase 1 study of carfilzomib with induction chemotherapy in children with relapsed or refractory ALL, enrolled 141 participants. NCT05848687, a recruiting Phase 1 trial for infants with ALL, plans to enroll 90 participants.
PEG asparaginase is a form of asparaginase that is pegylated. It is also known as pegaspargase, a common name for this drug. The trials listed use PEG asparaginase as part of combination regimens.