Clinical trial · Interventional
B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Extranodal NK/T-cell Lymphoma | Nasal Type Extranodal NK/T-Cell Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| B-MAD chemotherapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- B-MAD chemotherapy
- description
- Brentuximab Vedotin, Methotrexate, L-Asparaginase, and Dexamethasone
- interventionNames
- Drug: B-MAD chemotherapy
Primary outcomes (1)
- measure
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- description
- 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
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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
References
Publications (0)
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