A Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)

Last updated: January 24, 2025
Sponsor: Takeda
Overall Status: Active - Not Recruiting

Phase

2

Condition

Non-hodgkin's Lymphoma

Lymphoma

Treatment

Prednisone

Cyclophosphamide

Doxorubicin

Clinical Study ID

NCT05673785
C25024
  • Ages > 18
  • All Genders

Study Summary

This study will use a combination of Brentuximab vedotin with CHP to treat adult Chinese participants with CD30+ PTCL.

The main aims of the study are to evaluate:

  • Side effect from the A+CHP

  • Check how much A+CHP stays in their blood over time. This will help Takeda to work out the best dose to give people in the future.

  • If A+CHP improves outcome of newly diagnosed CD30+ PTCL

Brentuximab vedotin will be given through vein on Day 1 of each 21-day cycle. Cyclophosphamide and doxorubicin will be given through vein. Prednisone will be given orally daily on Days 1 through 5.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Participants must have newly diagnosed CD30+ PTCL, per the Revised European AmericanLymphoma 2016 World Health Organization (WHO) classification, by local assessment.Tumor specimen must be submitted before enrollment for subsequent central pathologyreview to confirm histology (and anaplastic lymphoma kinase (ALK) status, ifapplicable), and CD30 expression. Eligible histologies include:

  2. ALK-positive systemic anaplastic large cell lymphoma (sALCL) with anInternational Prognostic Index (IPI) score of ≥2.

  3. ALK-negative sALCL.

  4. PTCL- not otherwise specified (NOS).

  5. Angioimmunoblastic T-cell lymphoma (AITL).

  6. Enteropathy associated T-cell lymphoma (EATL).

  7. Hepatosplenic T-cell lymphoma (HSTCL).

  8. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equalto 2.

  9. Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) imagingand measurable disease with at least 1 bidimensionally measurable lesion (>1.5 cm inits largest dimension) by computed tomography (CT).

  10. Suitable venous access for the study-required blood sampling, includingpharmacokinetic (PK) and immunogenicity sampling.

  11. Clinical laboratory values as specified below at screening/baseline within 7 daysbefore the first dose of study drug:

  12. Total bilirubin must be ≤1.5 times the upper limit of normal (ULN) or ≤3 timesthe ULN for participants with Gilbert's disease or documented hepaticinvolvement with lymphoma.

  13. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤3times the ULN or ≤5 times the ULN for participants with an elevation that canbe reasonably ascribed to the presence of metastatic disease in liver.

  14. Serum creatinine must be <2.0 milligram per deciliter (mg/dL) and/or creatinineclearance or calculated creatinine clearance >40 milliliter (mL)/minute.

  15. Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusionis allowed ≥14 days before assessment.)

  16. Absolute neutrophil count >1.5×10^9/liter (L).

  17. Platelet count ≥75×10^9/L (unless documented bone marrow involvement withlymphoma).

Exclusion

Exclusion Criteria:

  1. Systemic anticancer therapy, including traditional Chinese medicine with antitumorindication for disease under study before the first dose of study drugs.

  2. Major surgery within 28 days before the first dose of study drug.

  3. Known human immunodeficiency virus (HIV)-positive status.

  4. Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or activehepatitis C virus infection. Note: Participants who have positive HBV core antibody and are HBsAg negative can beenrolled, but must have an undetectable HBV viral load.

  5. Diagnosed or treated for another malignancy within 3 years before the first dose orpreviously diagnosed with another malignancy and have any evidence of residualdisease. Participants with nonmelanoma skin cancer or carcinoma in situ of any typeare not excluded if they have undergone complete resection.

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

  7. Left-ventricular ejection fraction <45%.

  8. Myocardial infarction within 6 months of enrollment.

  9. New York Heart Association Class III or IV heart failure.

  10. Participants with current diagnosis of primary cutaneous CD30+ T-celllymphoproliferative disorders and lymphomas. Participants with cutaneous anaplasticlarge cell lymphoma (ALCL) with extracutaneous tumor spread beyond locoregionallymph nodes are eligible (previous single-agent treatment to address cutaneous andlocoregional disease is permissible).

  11. Participants with mycosis fungoides (MF) [including transformed MF].

  12. Uncontrolled diabetes mellitus.

  13. Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute CommonTerminology Criteria for Adverse Events [NCI CTCAE], version 5.0).

  14. History of progressive multifocal leukoencephalopathy (PML).

  15. Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.

Study Design

Total Participants: 52
Treatment Group(s): 4
Primary Treatment: Prednisone
Phase: 2
Study Start date:
February 10, 2023
Estimated Completion Date:
December 31, 2027

Study Description

The drug being tested in this study is called brentuximab vedotin. Brentuximab vedotin is being tested to treat CD30+ PTCL in Chinese participants. This study will look at the efficacy, safety, and pharmacokinetics (PK) of A+CHP as frontline treatment for newly diagnosed CD30+ PTCL.

The study will enroll approximately 52 participants. Participants will be enrolled in a single group to receive:

• Brentuximab vedotin 1.8 milligrams per kilogram (mg/kg) + Cyclophosphamide 750 milligrams per square meter (mg/m^2), Doxorubicin 50 mg/m^2 and Prednisone 100 mg

This multi-center trial will be conducted in China. The overall time to participate in this study is approximately 36 months.

Connect with a study center

  • Beijing Cancer Hospital

    Beijing, 100142
    China

    Site Not Available

  • Peking University Third Hospital

    Beijing, 100191
    China

    Site Not Available

  • The First Hospital of Jilin University

    Changchun, 130021
    China

    Site Not Available

  • West China Hospital, Sichuan University

    Chengdu, 610041
    China

    Site Not Available

  • Chongqing University Cancer Hospital

    Chongqing, 400030
    China

    Site Not Available

  • Fujian Medical University Union Hospital

    Fuzhou, 350001
    China

    Site Not Available

  • Guangdong Provincial Peoples Hospital

    Guangzhou, 510080
    China

    Site Not Available

  • The First Affiliated Hospital of Zhejiang University school of medicine

    Hangzhou, 310003
    China

    Site Not Available

  • Anhui Provincial Cancer Hospital

    Hefei, 230088
    China

    Site Not Available

  • Shandong Cancer Hospital

    Jinan, 250117
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Site Not Available

  • Fudan University Shanghai Cancer Center

    Shanghai, 200032
    China

    Site Not Available

  • Shengjing Hospital of China Medical University

    Shenyang, 110022
    China

    Site Not Available

  • The First Affiliated Hospital of Soochow University

    Suzhou, 215004
    China

    Site Not Available

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060
    China

    Site Not Available

  • Henan Cancer Hospital

    Zhengzhou, 450003
    China

    Site Not Available

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