Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pegaspargase · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Initial Low Risk (Initial LR) | OTHER | Meets all the following criteria: B-ALL, Age 1-\<15 years, WBC \< 50,000/microliter, CNS-1 or CNS-2, no BCR-ABL1, no iAMP21, and no VHR characteristics. Treated with Induction IA (vincristine, dexamethasone, pegaspargase), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA. |
| Initial High Risk (Initial HR) | OTHER | Meets at least one of the following criteria: Age \>=15 years, WBC \>=50,000/microliter, CNS-3, T-ALL, iAMP21, BCR-ABL1 And: No VHR characteristics Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA. |
| Initial Very High Risk (Initial VHR) | OTHER | Any of the following are present: IKZF1 deletion, MLL (KMT2A) rearrangement, low hypodiploidy, t(17;19) Treated with Induction IA (vincristine, dexamethasone, pegaspargase, doxorubicin + dexrazoxane), Induction IB (cyclophosphamide, cytarabine, mercaptopurine), Consolidation IA (vincristine, high-dose methotrexate + leucovorin, mercaptopurine). IT chemotherapy in all phases. Final risk group assigned by end of Consolidation IA. |
| Final Low Risk (Final LR) | OTHER | Initial Low Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, methotrexate, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission. |
| Final Intermediate Risk (Final IR) | OTHER | Initial High Risk and Low MRD (\<0.0001) at first time point (Day 32) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission. |
| Final High Risk (Final HR) | OTHER | Initial Low Risk or Initial High Risk with High MRD (\>=0.0001) at first time point (Day 32) but low MRD (\<0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by randomization or direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). All treatment completed 24 months from date of complete remission. |
| Final Very High Risk (Final VHR) | OTHER | Initial VHR or any patient with high MRD (\>=0.001) at second time point (week 10-12) Final Risk Group assigned at end of Consolidation IA. Subsequent therapy as follows: Consolidation IB/B-ALL (High-dose methotrexate + leucovorin, cyclophosphamide, etoposide, IT chemotherapy); Consolidation IB/T-ALL (nelararbine, cyclophosphamide, etoposide); Consolidation IC (High-dose cytarabine, etoposide, dexamethasone, pegaspargase \[by direct assignment\], IT chemotherapy); CNS phase (vincristine, dexamethasone, mercaptopurine, pegaspargase \[by direct assignment\], IT chemotherapy); Consolidation II (vincristine, dexamethasone, mercaptopurine, doxorubicin + dexrazoxane, pegaspargase \[by direct assignment\], IT chemotherapy); Continuation (vincristine, dexamethasone, mercaptopurine, methotrexate, IT chemotherapy). Dasatinib administered daily during all phases to pts with ABL1-class fusions. All treatment completed 24 months from date of complete remission. |
| Fixed Dose Pegaspargase | ACTIVE_COMPARATOR | Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks at standard fixed-dose (2500 IU/m2/dose). |
| Reduced Dose (PK-Adjusted) Pegaspargase | EXPERIMENTAL | Final LR, IR, HR patients who consent to randomization and are assigned to receive 15 doses of pegaspargase every 2-weeks beginning at a reduced dose (2000 IU/m2/dose); subsequent doses adjusted based on nadir serum asparaginase activity (NSAA) levels, with goal of maintaining NSAA between 0.4 and 1.0 IU/mL. Closed to Enrollment. |
| Direct Assignment | OTHER | All VHR patients, and any Final LR, IR, HR patients who decline randomization: Assigned to receive standard dosing of pegaspargase (15 doses of pegaspargase every 2-weeks at standard fixed-dose; 2500 IU/m2/dose). |
| Name | Type | Description |
|---|---|---|
| Pegaspargase | DRUG | Arm A: Standard/Fixed Dose Pegaspargase (2500 IU/m2 every 2 weeks) Arm B: Reduced Dose (PK-adjusted) Pegaspargase (Starting Dose: 2000 IU/m2) Arm X: Directly Assigned Standard Dose (2500 IU/m2): For all VHR and patients who decline randomization |
| Erwinia asparaginase | DRUG | Only for patients with Pegaspargase allergy or silent inactivation. |
| Cyclophosphamide | DRUG | Standard of Care |
| CYTARABINE | DRUG | Standard of Care |
| DASATINIB | DRUG | Standard of Care |
| DEXAMETHASONE | DRUG | Standard of Care |
| Dexrazoxane | DRUG | Standard of Care |
| Doxorubicin | DRUG | Standard of Care |
| ETOPOSIDE | DRUG | Standard of Care |
| HYDROCORTISONE | DRUG | Standard of Care |
| LEUCOVORIN CALCIUM | DRUG | Standard of Care |
| MERCAPTOPURINE | DRUG | Standard of Care |
| METHOTREXATE | DRUG | Standard of Care |
| NELARABINE | DRUG | Standard of Care |
| Vincristine | DRUG | Standard of Care |
Inclusion Criteria: 1. Confirmed diagnosis of acute lymphoblastic leukemia. Diagnosis should be made by bone marrow aspirate or biopsy demonstrating ≥ 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype. \-- For patients with ci...
Pegaspargase is an investigational small molecule being studied for the treatment of newly diagnosed Acute Lymphoblastic Leukemia (ALL) in pediatric patients. It is currently in Phase 3 clinical development and is being evaluated in children and adolescents aged 1 year and older.
Pegaspargase is being developed by Tango Therapeutics, Inc. (NASDAQ: TNGX). The company is conducting a Phase 3 clinical trial of Pegaspargase for pediatric Acute Lymphoblastic Leukemia.
Pegaspargase is currently in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 3 trial is active but not recruiting participants.
Pegaspargase is being studied in one Phase 3 clinical trial, NCT03020030, titled 'Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Children and Adolescents.' The trial is active but not recruiting, with an enrollment of 560 participants across the United States and Canada.
Pegaspargase is the drug name used in the clinical trial NCT03020030. No alternative names for Pegaspargase have been reported in the trial information.