A Study of Brentuximab Vedotin Treatment in Chinese Adults With CD30-Positive Cutaneous T-Cell Lymphoma

Last updated: September 12, 2024
Sponsor: Takeda
Overall Status: Completed

Phase

4

Condition

T-cell Lymphoma

Lymphoma

Lymphoproliferative Disorders

Treatment

Brentuximab vedotin

Clinical Study ID

NCT05442554
C25029
  • Ages > 18
  • All Genders

Study Summary

The main aim is to check the long-term side effects of treatment with Brentuximab Vedotin and to see if that treatment improves symptoms of cluster of differentiation antigen 30 (CD30-Positive) Cutaneous T-Cell Lymphoma in Chinese adults.

Participants will receive brentuximab vedotin through the vein on day 1 of each 21 day cycle up to maximum 16 cycles.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histologically- confirmed cluster of differentiation antigen 30 positive (CD30+)disease by local laboratory assessment and pathology review.

  2. Participants with primary cutaneous anaplastic large cell lymphoma (pcALCL) who havereceived prior radiation therapy or at least 1 prior systemic therapy, orparticipants with mycosis fungoides (MF) who have received at least 1 prior systemictherapy for their disease. 3. Eastern Cooperative Oncology Group (ECOG) performancestatus of ≤2. 4. Suitable venous access for the study-required blood sampling. 5.Participants must have radiographically or clinically measurable or evaluabledisease.

  3. Recovered (i.e., Grade 1 toxicity) from the reversible effects of priorantineoplastic therapy.

Exclusion

-Exclusion Criteria:

  1. A concurrent diagnosis of systemic anaplastic large cell lymphoma (ALCL), or othernon-Hodgkin lymphoma (excluding lymphomatoid papulosis [LyP]).

  2. A concurrent diagnosis of sézary syndrome (SS) or high blood tumor burden (B2)disease.

  3. Corticosteroid therapy for the treatment of cutaneous T-cell lymphoma (CTCL) within 3 weeks of first dose of study drug.

  4. Known hypersensitivity to recombinant proteins, murine proteins, or any excipientcontained in the drug formulation.

  5. Life-threatening illness unrelated to cancer.

  6. Severe central nervous system (CNS), pulmonary, renal, or hepatic disease notrelated to the participant's cancer.

  7. Known active cerebral/meningeal disease, including signs or symptoms of progressivemultifocal leukoencephalopathy (PML).

  8. Known human immunodeficiency virus (HIV) positive.

  9. Known hepatitis B surface antigen positive or known or suspected active hepatitis Cinfection.

  10. Any severe active systemic viral, bacterial, or fungal infection within 1 weekbefore first study drug dose requiring systemic antimicrobial therapy. (Oralantibiotics for prophylaxis are allowed.)

  11. Receiving antibody-directed or immunoglobulin-based immune therapy (eg,immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks offirst study drug dose.

  12. Any of the following cardiovascular conditions or values within 6 months before thefirst dose of study drug:

  • Myocardial infarction within 6 months of enrollment.

  • New York Heart Association (NYHA) Class III or IV heart failure.

  • Evidence of current uncontrolled cardiovascular conditions, including cardiacarrhythmias, congestive heart failure (CHF), angina, or electrocardiographicevidence of acute ischemia or active conduction system abnormalities.

  1. History of another primary malignancy not in remission for at least 3 years. Thefollowing are exempt from the 3-year limit: completely resected in situ carcinoma,such as nonmelanoma skin cancer and cervical carcinoma in situ on biopsy or asquamous intraepithelial lesion on Pap smear.

  2. Oral retinoid therapy for any indication within 3 weeks of the first dose of studydrug.

  3. History of pancreatitis or significant risk factors for developing pancreatitis (eg,prior pancreatitis, uncontrolled hyperlipidemia, excessive alcohol consumption,uncontrolled diabetes mellitus, biliary tract disease, and medications known toincrease triglyceride levels or to be associated with pancreatic toxicity).

Study Design

Total Participants: 10
Treatment Group(s): 1
Primary Treatment: Brentuximab vedotin
Phase: 4
Study Start date:
July 20, 2023
Estimated Completion Date:
August 09, 2024

Study Description

The drug being tested in this study is called brentuximab vedotin (SGN-35). Brentuximab vedotin is being tested to treat people who have CD30-positive cutaneous T-Cell lymphoma.

The study will enroll approximately 10 patients. Participants will receive a single treatment i.e., brentuximab vedotin monotherapy:

• Brentuximab vedotin 1.8 mg/kg

Participants will be administered with brentuximab vedotin by intravenous (IV) infusion given for approximately 30 minutes on Day 1 of each 21-day cycle up to 16 cycles followed by the end of treatment (EOT) visit 30 days after receiving the final dose of study drug. Participants with progressive disease (PD) at any time during the study will be discontinued from study drug.

This multi-center trial will be conducted in China. Participants will remain in this study for approximately 56 weeks.

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, Beijing 100191
    China

    Site Not Available

  • Huashan Hospital, Fudan University

    Shanghai, Shanghai 200040
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, Sichuan 610041
    China

    Site Not Available

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