Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Information source: Seoul National University Hospital
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsed or Refractory EBV-and CD30-positive Lymphomas
Intervention: brentuximab vedotin (Drug)
Phase: Phase 2
Status: Not yet recruiting
Sponsored by: Seoul National University Hospital Official(s) and/or principal investigator(s): Tae Min Kim, MD, PhD, Principal Investigator, Affiliation: Seoul National University Hospital
Overall contact: Tae Min Kim, MD, PhD, Phone: 82-2-2072-3559, Email: gabriel9@snu.ac.kr
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.
Clinical Details
Official title: A Phase II Study of Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate the overall response rate (ORR) of brentuximab vedotin in EBV- and CD30-positive lymphomas
Secondary outcome: To evaluate the safety profile of brentuximab vedotin using CTCAE version 4.03To calculate progression-free survival (PFS) time To calculate the duration of response To calculate overall survival (OS) time
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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that consent may be withdrawn by the patient at any time without prejudice to future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.
Locations and Contacts
Tae Min Kim, MD, PhD, Phone: 82-2-2072-3559, Email: gabriel9@snu.ac.kr Additional Information
Starting date: April 2015
Last updated: March 9, 2015
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