Status:
COMPLETED
B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T-cell Lymphoma
Lead Sponsor:
The Thai Lymphoma Study Group
Collaborating Sponsors:
Takeda
Conditions:
Extranodal NK/T-cell Lymphoma
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
PHASE2
Brief 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 N...
Detailed Description
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 N...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2024
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT03246750
Start Date
January 30 2019
End Date
April 10 2024
Last Update
April 17 2024
Active Locations (1)
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1
King Chulalongkorn Memorial Hospital
Bangkok, Thailand, 10330