Clinical trial NCT02388490: Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Official title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Relapsed or Refractory EBV-and CD30-positive Lymphomas
Keywords: Brentuximab vedotin
EBV
Lymphoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University Bundang Hospital
name: SMG-SNU Boramae Medical Center
First posted: 2015-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas.

Detailed description: This is an open-label, non-randomized, multi-center, phase II trial of brentuximab vedotin to evaluate ORR primarily in patients with EBV- and CD30-positive lymphomas. The ORR will be evaluated based on the revised Cheson's criteria or modified SWAT criteria in case of cutaneous EBV- and CD30-positive lymphomas.

Eligibility criteria: Inclusion Criteria:

1. Patients with relapsed or refractory EBV- and CD30-positive lymphomas
2. Age ≥ 18 years
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. 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of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.
7. Female patient is either post-menopausal for at least 1 year before the screening visit or surgically sterile or if of childbearing potential, agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
8. Male patients, even if surgically sterilized, (i.e., status post vasectomy) agree to practice effective barrier contraception during the entire study period and through 6 months after the last dose of study drug, or agrees to completely abstain from heterosexual intercourse.
9. 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)
10. Adequate liver function: total bilirubin \< 1.5 x the upper limit of the normal (ULN) unless the elevation is known to be due to Gilbert syndrome and ALT or AST \< 3 x ULN (AST and AST \< 5 x ULN if their elevation can be reasonably ascribed to the presence of hematologic tumor in liver)
11. Adequate renal function: serum creatinine \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute.
12. Expected survival \> 3 months

Exclusion Criteria:

1. Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
2. Any serious medical or psychiatric illness
3. Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
4. Symptomatic neurologic disease compromising normal activities or requiring medication
5. Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
6. Known history of myocardial infarction within 1 year, NYHA class III/IV heart failure, or uncontrolled cardiovascular conditions including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. 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 within 2 weeks prior to first study drug dose
8. Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
9. Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
10. Prior exposure to CD30-targeted agents
11. Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
12. Known human immunodeficiency virus (HIV) positive
13. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
14. Another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have evidence of residual disease. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

Primary outcomes:
measure: To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas
timeFrame: One-year
Secondary outcomes:
measure: To Evaluate the Safety Profile
timeFrame: From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 days
measure: To Calculate Progression-free Survival (PFS) Time
timeFrame: One-year
measure: To Calculate the Duration of Response
timeFrame: From the first dose Up to the time of data cut-off.
measure: To Calculate Overall Survival (OS) Time
timeFrame: From first dose to end of data collection
Other outcomes:
measure: The Number of Participants With a Tumor Response Stratified by CD30-positive Expression
timeFrame: One-year
measure: Exploratory.
timeFrame: On the date of screening visit.
measure: The ORR in the Groups With High sCD30 (≥ 99.03 ng/mL) and Low sCD30 (<99.03 ng/mL).
timeFrame: Up to the date of data cut-off
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Unversity Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
Study officials:
affiliation: Seoul National University Hospital
name: Tae Min Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim M, Lee JO, Koh J, Kim TM, Lee JY, Jeon YK, Keam B, Kim DW, Lee JS, Heo DS. A phase II study of brentuximab vedotin in patients with relapsed or refractory Epstein-Barr virus-positive and CD30-positive lymphomas. Haematologica. 2021 Aug 1;106(8):2277-2280. doi: 10.3324/haematol.2021.278301. No abstract available.