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

• Status: Recruiting
• Trial end date: 2023-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Thai Lymphoma Study Group
• Collaborator: Takeda
• Treatments: Antibodies, Monoclonal; Asparaginase; Cisplatin; Dexamethasone; Methotrexate

Criteria

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 other subtypes of non-Hodgkin lymphoma, including myeloid/NK cell precursor acute leukemia, blastic NK cell lymphoma/precursor NK cell lymphoblastic leukemia, aggressive NK cell leukemia, and peripheral T cell lymphoma, unspecified

• Prior chemotherapy or radiotherapy for ENKTL

• Seropositivity for HIV and severe infection

• Prior or other concomitant malignant tumors

• Pregnant or breastfeeding patients

• Evidence of any other disease or medical conditions that contraindicate use of the study drug, or patients at high risk from treatment complications

• Patients suffering from psychiatric disorders