None listed
Conditions
Interventions
Drug : brentuximab vedotin will be administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg. Dosing is based on subj
however, doses will be adjusted for subjects who experience a = 10% change in weight from baseline. Actual weight will be used except for subjects weighing greater than 100 kg
dose will be calculated based on 100 kg for these individuals. The dose will be rounded to the nearest whole number of milligrams. Subjects may receive up to 16 cycles of brentuximab vedotin.
Sponsors
Seoul National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects 18 years or older 2. Subjects with relapsed or refractory EBV- and CD30-positive lymphomas a. EBV-positivity determined by EBV in situ hybridization at participating centers i. Extranodal NK/T-cell lymphoma, nasal type ii. EBV-positive peripheral T-cell lymphoma, not otherwise specified iii. EBV-positive diffuse large B-cell lymphoma of the elderly iv. Plasmablastic lymphoma v. Lymphomatoid granulomatosis vi. Hydroa vacciniform-like T-cell lymphoma vii. Other EBV-positive lymphoproliferative disorders b. CD30-positivity determined by a specialized hemato-pathologist. CD30 positivity defined as 1% or greater tumor cells expressing CD30 at any intensity greater than or equal to 1+ with any cellular distribution pattern. c. Relapsed or refractory disease that fails to at least one and maximum four regimens including anthracycline-based chemotherapy; if anthracycline-based regimen is not standard treatment of certain subtypes (e.g. hydroa vacciniforme-like T-cell lymphoma or EBV-positive lymphoproliferative disorder, etc), a prior chemotherapy is acceptable. 3. ECOG Performance status 0-2 4. At least one measurable lesion based on revised Cheson’s or modified SWAT criteria 5. Provision archival tumor tissues (4 µm thickness x 5 unstained slides) and blood samples 6. Adequate hematologic function: absolute neutrophil count (ANC) =1,500/µL, platelet count = 75,000/µL, and hemoglobin =8.0 g/dL unless there is known hematologic tumor marrow involvement (ANC = 1,000/µL and platelet count = 50,000/µL if there is known bone marrow involvement) 7. Adequate liver function: total bilirubin 40 mL/minute. 9. Expected survival > 3 months 10. Voluntary written informed consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care.
Exclusion criteria
Exclusion criteria: 1. Female subject who are both lactating and breast-feeding or have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug 2. Any serious medical or psychiatric illness that could, in the investigator’s opinion, potentially interfere with the completion of treatment according to the protocol. 3. Known cerebral or meningeal disease (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML 4. Symptomatic neurologic disease compromising normal activities of daily living or requiring medications 5. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2 6. Known history of any of the following cardiovascular conditions a. Myocardial infarction within 1 year of study enrollment b. New York Heart Association (NYHA) Class III or IV heart failure (see Appendix 12.2) c. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities d. Recent evidence (within 6 months before first dose of study drug) of a left-ventricular ejection fraction <50% 7. Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose 8. Subjects that have not completed any prior treatment chemotherapy and/or other investigational agents within at least 5 half-lives of last dose of that prior treatment 9. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin. 10. Known human immunodeficiency virus (HIV) positive 11. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection 12. Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Subjects with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| the safety profile;progression-free survival;the duration of response;overall survival time | — |
Countries
Korea, Republic of
Contacts
Public ContactTaeMin Kim
Seoul National University Hospital
Outcome results
None listed