Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas

NCT02388490 | Completed Phase 2 Results

• 1 other identifier: X25016
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

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.

Conditions

Relapsed or Refractory EBV-and CD30-positive Lymphomas

Keywords

Brentuximab vedotin; EBV; Lymphoma

Outcome Measures

Primary Outcomes (1)

• To Evaluate the Overall Response Rate (ORR) of Brentuximab Vedotin in EBV- and CD30-positive Lymphomas

  The primary endpoint was the ORR based on the revised criteria or modified Severity Weighted Assessment Tool (SWAT) criteria in the case of cutaneous lymphomas.

  One-year

Secondary Outcomes (4)

• To Evaluate the Safety Profile

  From the first dose of brentuximab vedotin to up to 30 days after the last dose, a total of up to approximately 366 days

• To Calculate Progression-free Survival (PFS) Time

  One-year

• To Calculate the Duration of Response

  From the first dose Up to the time of data cut-off.

• To Calculate Overall Survival (OS) Time

  From first dose to end of data collection

Other Outcomes (3)

• The Number of Participants With a Tumor Response Stratified by CD30-positive Expression

  One-year

• Exploratory.

  On the date of screening visit.

• The ORR in the Groups With High sCD30 (≥ 99.03 ng/mL) and Low sCD30 (<99.03 ng/mL).

  Up to the date of data cut-off

Study Arms (1)

Brentuximab vedotin

EXPERIMENTAL

Brentuximab vedotin is an antibody-drug conjugate (ADC) composed of the anti-CD30 chimeric immunoglobulin G1 (IgG1) monoclonal antibody cAC10 and the potent antimicrotubule drug monomethyl auristatin E connected by a protease-cleavable linker. cAC10 binds to the CD30 antigen, which has a very low expression on normal cells but is found on some tumor cells.

Drug: brentuximab vedotin

Interventions

brentuximab vedotin DRUG

Brentuximab vedotin 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 q 3 weeks.

Also known as: Adcetris

Brentuximab vedotin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with relapsed or refractory EBV- and CD30-positive lymphomas
• Age ≥ 18 years
• ECOG performance status 0-2
• At least one measurable lesion based on revised Cheson's or modified SWAT criteria
• Provision archival tumor tissues (4 μm thickness x 5 unstained slides) and blood samples
• 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.
• 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.
• 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.
• 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)
• 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)
• Adequate renal function: serum creatinine \< 2.0 mg/dL and/or creatinine clearance or calculated creatinine clearance \> 40 mL/minute.
• Expected survival \> 3 months

You may not qualify if:

• Female patient who are both lactating and breast-feeding or have a positive serum pregnancy test
• Any serious medical or psychiatric illness
• Known cerebral or meningeal involvement (EBV- and CD30-positive lymphoma or any other etiology), including signs or symptoms of PML
• Symptomatic neurologic disease compromising normal activities or requiring medication
• Any sensory or motor peripheral neuropathy greater than or equal to Grade 2
• 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%.
• Any active systemic viral, bacterial, or fungal infection within 2 weeks prior to first study drug dose
• Any prior chemotherapy and/or other investigational agents within at least 5 half-lives of last dose
• Prior stem cell transplantation within 100 days or radioimmunotherapy within 8 weeks
• Prior exposure to CD30-targeted agents
• Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin
• Known human immunodeficiency virus (HIV) positive
• Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection
• 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.

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Seoul National University Bundang Hospital: collaborator
• SMG-SNU Boramae Medical Center: collaborator

Study Sites (3)

Seoul National University Bundang Hospital

Seongnam, South Korea

Location

Seoul National Unversity Hospital

Seoul, South Korea

Location

SMG-SNU Boramae Medical Center

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 33792222 DERIVED

MeSH Terms

Conditions

Recurrence; Lymphoma

Interventions

Brentuximab Vedotin

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Tae Min Kim
• Organization: Seoul National University Hospital

gabriel9@snu.ac.kr

82+2-2072-3559

Study Officials

• Tae Min Kim, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2015
• First Posted: March 17, 2015
• Study Start: March 25, 2016
• Primary Completion: April 2, 2019
• Study Completion: April 2, 2019
• Last Updated: September 23, 2024
• Results First Posted: September 23, 2024

Record last verified: 2019-04

Locations

KR (3)