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

NCT ID: NCT02388490

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-25
• Study Completion Date: 2019-04-02

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.

Conditions

Relapsed or Refractory EBV-and CD30-positive Lymphomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brentuximab vedotin

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.

Group Type: EXPERIMENTAL

brentuximab vedotin

Intervention Type: 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.

Interventions

brentuximab vedotin

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.

Intervention Type: DRUG

Other Intervention Names

Adcetris

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

SMG-SNU Boramae Medical Center

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tae Min Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Seoul National Unversity Hospital

Seoul, , South Korea

SMG-SNU Boramae Medical Center

Seoul, , South Korea

Countries

South Korea

References

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.

Reference Type: DERIVED

PMID: 33792222 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

X25016

Identifier Type: -

Identifier Source: org_study_id