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)

NCT05673785 | Active Not Recruiting Phase 2

• 1 other identifier: C25024
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 16

Brief 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.

Conditions

Lymphoma

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment per Revised Response Criteria for Malignant Lymphoma

  ORR by IRF assessment following the completion of study treatment is defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) by IRF assessment using the International Working Group (IWG) Revised Response criteria following the completion of study treatment. CR is defined as disappearance of all evidence of disease. PR is defined as regression of measurable disease and no new sites.

  Up to approximately 7 months

• Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)

  An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. A TEAE is defined as an adverse event that occurs after administration of the first dose of study treatment and up through 30 days after the last dose of study treatment.

  Up to approximately 7 months

• Percentage of Participants With Clinically Significant Laboratory Test Values

  Clinical laboratory tests will include hematocrit, hemoglobin, platelet (count), white blood cell (WBC) count, absolute neutrophil count (ANC), alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin (total), albumin, alkaline phosphatase, blood urea nitrogen, calcium, chloride, gamma glutamyl transferase, glucose, lactate dehydrogenase, phosphate, potassium, sodium, urate and creatinine evaluations. Any value outside the normal range will be flagged for the attention of the investigator who will assess whether or not a flagged value is of clinical significance.

  Up to approximately 7 months

• Percentage of Participants With Clinically Significant Vital Signs

  Vital signs will include measurements of diastolic and systolic blood pressure, heart rate, and body temperature. Any value outside the normal range will be flagged for the attention of the investigator who will assess whether or not a flagged value is of clinical significance.

  Up to approximately 7 months

Secondary Outcomes (11)

• CR Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma

  Up to approximately 7 months

• 1-Year Progression Free Survival (PFS) Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma

  Up to approximately 12 months

• 1-Year Overall Survival (OS) Rate

  Up to approximately 12 months

• ORR by IRF and Investigator Assessment per 2014 Lugano Classification

  Up to approximately 7 months

• CR Rate by IRF and Investigator Assessment per 2014 Lugano Classification

  Up to approximately 7 months

Study Arms (1)

Brentuximab Vedotin + CHP

EXPERIMENTAL

Brentuximab vedotin 1.8 mg/kg, intravenous (IV) infusion, within 1 hour of completing treatment with other IV agents, i.e., cyclophosphamide 750 mg/m\^2 and doxorubicin 50 mg/m\^2 IV, on Day 1 of each 21-day cycle, and prednisone 100 mg tablets, orally, on Days 1 through Day 5, for up to 8 cycles (6 months) or until progressive disease (PD), unacceptable toxicity, whichever occurs first.

Drug: Brentuximab Vedotin; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Prednisone

Interventions

Brentuximab Vedotin DRUG

Brentuximab vedotin IV infusion

Brentuximab Vedotin + CHP

Cyclophosphamide DRUG

Cyclophosphamide IV infusion

Brentuximab Vedotin + CHP

Doxorubicin DRUG

Doxorubicin IV infusion

Brentuximab Vedotin + CHP

Prednisone DRUG

Prednisone tablets

Brentuximab Vedotin + CHP

Eligibility Criteria

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

You may qualify if:

• Participants must have newly diagnosed CD30+ PTCL, per the Revised European American Lymphoma 2016 World Health Organization (WHO) classification, by local assessment. Tumor specimen must be submitted before enrollment for subsequent central pathology review to confirm histology (and anaplastic lymphoma kinase (ALK) status, if applicable), and CD30 expression. Eligible histologies include:
• ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (IPI) score of ≥2.
• ALK-negative sALCL.
• PTCL- not otherwise specified (NOS).
• Angioimmunoblastic T-cell lymphoma (AITL).
• Enteropathy associated T-cell lymphoma (EATL).
• Hepatosplenic T-cell lymphoma (HSTCL).
• Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2.
• Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) imaging and measurable disease with at least 1 bidimensionally measurable lesion (\>1.5 cm in its largest dimension) by computed tomography (CT).
• Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and immunogenicity sampling.
• Clinical laboratory values as specified below at screening/baseline within 7 days before the first dose of study drug:
• Total bilirubin must be ≤1.5 times the upper limit of normal (ULN) or ≤3 times the ULN for participants with Gilbert's disease or documented hepatic involvement with lymphoma.
• Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) must be ≤3 times the ULN or ≤5 times the ULN for participants with an elevation that can be reasonably ascribed to the presence of metastatic disease in liver.
• Serum creatinine must be \<2.0 milligram per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance \>40 milliliter (mL)/minute.
• Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusion is allowed ≥14 days before assessment.)

You may not qualify if:

• Systemic anticancer therapy, including traditional Chinese medicine with antitumor indication for disease under study before the first dose of study drugs.
• Major surgery within 28 days before the first dose of study drug.
• Known human immunodeficiency virus (HIV)-positive status.
• Known hepatitis B virus (HBV) surface antigen (HBsAg) seropositivity or active hepatitis C virus infection.
• Note: Participants who have positive HBV core antibody and are HBsAg negative can be enrolled, but must have an undetectable HBV viral load.
• Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
• Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
• Left-ventricular ejection fraction \<45%.
• Myocardial infarction within 6 months of enrollment.
• New York Heart Association Class III or IV heart failure.
• Participants with current diagnosis of primary cutaneous CD30+ T-cell lymphoproliferative disorders and lymphomas. Participants with cutaneous anaplastic large cell lymphoma (ALCL) with extracutaneous tumor spread beyond locoregional lymph nodes are eligible (previous single-agent treatment to address cutaneous and locoregional disease is permissible).
• Participants with mycosis fungoides (MF) \[including transformed MF\].
• Uncontrolled diabetes mellitus.
• Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\], version 5.0).
• History of progressive multifocal leukoencephalopathy (PML).

Sponsors & Collaborators

• Takeda: lead

Study Sites (16)

Beijing Cancer Hospital

Beijing, 100142, China

Location

Peking University Third Hospital

Beijing, 100191, China

Location

The First Hospital of Jilin University

Changchun, 130021, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

Chongqing University Cancer Hospital

Chongqing, 400030, China

Location

Fujian Medical University Union Hospital

Fuzhou, 350001, China

Location

Guangdong Provincial Peoples Hospital

Guangzhou, 510080, China

Location

The First Affiliated Hospital of Zhejiang University school of medicine

Hangzhou, 310003, China

Location

Anhui Provincial Cancer Hospital

Hefei, 230088, China

Location

Shandong Cancer Hospital

Jinan, 250117, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, 330006, China

Location

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

Location

Shengjing Hospital of China Medical University

Shenyang, 110022, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215004, China

Location

Tianjin Medical University Cancer Institute & Hospital

Tianjin, 300060, China

Location

Henan Cancer Hospital

Zhengzhou, 450003, China

Location

Related Links

• To obtain more information on the study, click here/on this link

MeSH Terms

Conditions

Lymphoma

Interventions

Brentuximab Vedotin; Cyclophosphamide; Doxorubicin; Prednisone

Condition Hierarchy (Ancestors)

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; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: January 4, 2023
• First Posted: January 6, 2023
• Study Start: February 10, 2023
• Primary Completion: April 27, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/ For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

CN (16)