Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
B-MAD chemotherapy · 1 trial · 1 indication
Patients will be assessed for dose-limiting toxicity (DLT) during the first cycle. DLTs are described as follows: For non-hematologic toxicities • Any related non-hematologic events of grade 3 or higher, with the exception of: * grade 3 fatigue * grade 3 or 4 nausea and vomiting lasting than 24 hours * grade 3 non-hematologic laboratory abnormalities resolving to grade 1 or baseline within 14 days * grade 3 or 4 allergic or hypersensitivity reaction For hematologic toxicities * Related grade 4 neutropenia lasting \> 7 days * Related grade 3 febrile neutropenia requiring antibiotics * Related grade 4 febrile neutropenia * Related grade 4 thrombocytopenia
| Arm | Type | Description |
|---|---|---|
| B-MAD chemotherapy | EXPERIMENTAL | Brentuximab Vedotin, Methotrexate, L-Asparaginase, and Dexamethasone |
| Name | Type | Description |
|---|---|---|
| B-MAD chemotherapy | DRUG | B-MAD chemotherapy |
Inclusion Criteria: * Patients with previously untreated ENKTL as defined by the World Health Organization (WHO) classification * Age 18-60 years * Localized (stage I, II) or advanced (stage III, IV) disease * Adequate organ function * Signed informed consent Exclusion Criteria: * Patients with o...