B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma

Summary

Study Title: Phase I/II study of brentuximab vedotin and methotrexate/ L-asparaginase/ dexamethasone (B-MAD) chemotherapy in patients with newly-diagnosed Extranodal NK/T-cell Lymphoma Phase: I/II Number of Patients: 36 Study Objectives Primary * To determine the safety and optimal dose of brentuximab vedotin when use in combination with methotrexate, L-asparaginase and dexamethasone in the treatment of newly-diagnosed ENKTL patients Secondary * To evaluate the clinical efficacy of this regimen * To access the overall responses including overall response rate (ORR), disease-free survival (DSF), progression-free survival (PFS). Overview of Study Design: Open-label, multicenter, non-randomized, 3+3 dose escalation study of brentuximab vedotin in combination with fixed-dose MAD chemotherapy. The first cycle will be evaluated for the determination of the recommended phase II dose. Patients will be received the treatment according to the stage of disease as follows: * Patients with localized ENKTL (stage IE or stage IIE) will receive involved-field radiation (IRFT) with concomitant weekly intravenous Cisplatin. Three to five weeks after the completion of IFRT and cisplatin, B-MAD (Brentuximab vedotin, Methotrexate, L-asparaginase and Dexamethasone) regimen will be given every 21 days for 3 cycles. * Patients with advanced ENKTL (stage III or stag IV) will receive B-MAD every 21 days for 6 cycles. Study Population: Patients with newly-diagnosed ENKTL will be screened for enrollment. Duration of Study: 3 years

Timeline

Start

2019-01-30

Primary completion

2024-04-10

Completion

2024-04-10

Drugs

Indications