B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma
Status:
Recruiting
Trial end date:
2023-06-01
Target enrollment:
Participant gender:
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