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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06738368 | Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombinant Erwinia Asparaginase (JZP458) for the Treatment of Newly Diagnosed Ph Negative B-Acute Lymphoblastic Leukemia or T Acute Lymphoblastic Leukemia | PHASE2 | RECRUITING | 30 | — | — | May 1, 2026 | Jul 30, 2028 | Apr 8, 2026 | 1 | United States |
Will be measured by multi-parameter flow cytometry (MFC). Will be assessed according to the National Comprehensive Cancer Network response criteria.
| Arm | Type | Description |
|---|---|---|
| Treatment (DA-EPOCH, rituximab, JZP458) | EXPERIMENTAL | Patients receive etoposide IV, doxorubicin IV and vincristine IV over 96 hours on days 1-4, cyclophosphamide IV over 1 hour on day 5, prednisone PO BID on days 1-5 of each cycle. In addition, CD20 positive patients receive rituximab IV on day 1 or 5 of each cycle. Patients also receive JZP458 IM every 2-3 days on days 7-21 for up to 7 doses. Cycles repeat every 21 days for up to 8 cycles in the absence of disease progression or unacceptable toxicity. Starting on day 6, 7, or 8, patients also receive pegfilgrastim SC once or filgrastim SC QD until ANC \> 2000/uL past nadir. Patients also undergo blood sample collection and bone marrow collection throughout the study. Additionally, patients with extramedullary disease may undergo CT or PET/CT throughout the study. |
| Name | Type | Description |
|---|---|---|
| Asparaginase Erwinia chrysanthemi | DRUG | Given IM |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Collection | PROCEDURE | Undergo bone marrow sample collection |
| Computed Tomography | PROCEDURE | Undergo CT or PET/CT |
| Cyclophosphamide | DRUG | Given IV |
| Doxorubicin | DRUG | Given CIV |
| Etoposide | DRUG | Given CIV |
| Filgrastim | BIOLOGICAL | Given SC |
| Pegfilgrastim | BIOLOGICAL | Given SC |
| Positron Emission Tomography | PROCEDURE | Undergo PET/CT |
| Prednisone | DRUG | Given PO |
| Rituximab | BIOLOGICAL | Given IV |
| Vincristine | DRUG | Given CIV |
Inclusion Criteria: * Adults (age 18 years and older) with newly-diagnosed Ph- B-ALL or T-ALL * In the opinion of the treating investigator, patients must be an unsuitable candidate for a pediatric-inspired regimen, reasons for which may include (but not be limited to) older age (e.g., ≥ 40 years),...