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Clinical Trials in China / NCT05673785
Active, not recruiting Phase 2

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 · tracked via the Priya Life Science China tracker
Sponsor
Takeda
Phase
Phase 2
Started
2023-02-10
Last updated
2026-06-12

Condition(s) studied

Lymphoma

Investigational drug(s) / intervention(s)

Brentuximab Vedotin →Cyclophosphamide →Doxorubicin →Prednisone →

Brentuximab Vedotin: Brentuximab vedotin IV infusion

Cyclophosphamide: Cyclophosphamide IV infusion

Doxorubicin: Doxorubicin IV infusion

Prednisone: Prednisone tablets

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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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: 1. ALK-positive systemic anaplastic large cell lymphoma (sALCL) with an International Prognostic Index (IPI) score of ≥2. 2. ALK-negative sALCL. 3. PTCL- not otherwise specified (NOS). 4. Angioimmunoblastic T-cell lymphoma (AITL). 5. Enteropathy associated T-cell lymphoma (EATL). 6. Hepatosplenic T-cell lymphoma (HSTCL). 2. Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2. 3. 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). 4. Suitable venous access for the study-required blood sampling, including pharmacokinetic (PK) and immunogenicity sampling. 5. Clinical laboratory values as specified below at screening/baseline within 7 days before the first dose of study drug: 1. 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. 2. 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. 3. Serum creatinine must be \<2.0 milligram per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance \>40 milliliter (mL)/minute. 4. Hemoglobin must be ≥8 grams per deciliter (g/dL). (Red blood cell transfusion is allowed ≥14 days before assessment.) 5. Absolute neutrophil count \>1.5×10\^9/liter (L). 6. Platelet count ≥75×10\^9/L (unless documented bone marrow involvement with lymphoma). Exclusion Criteria: 1. Systemic anticancer therapy, including traditional Chinese medicine with antitumor indication 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 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. 5. 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. 6. Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug: 1. Left-ventricular ejection fraction \<45%. 2. Myocardial infarction within 6 months of enrollment. 3. New York Heart Association Class III or IV heart failure. 7. 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). 8. Participants with mycosis fungoides (MF) \[including transformed MF\]. 9. Uncontrolled diabetes mellitus. 10. Baseline peripheral neuropathy ≥Grade 2 (National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\], version 5.0). 11. History of progressive multifocal leukoencephalopathy (PML). 12. Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.

Primary outcome measure(s)

Trial sites (16)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China
Peking University Third Hospital Beijing China
The First Hospital of Jilin University Changchun China
West China Hospital, Sichuan University Chengdu China
Chongqing University Cancer Hospital Chongqing China
Fujian Medical University Union Hospital Fuzhou China
Guangdong Provincial Peoples Hospital Guangzhou China
The First Affiliated Hospital of Zhejiang University school of medicine Hangzhou China
Anhui Provincial Cancer Hospital Hefei China
Shandong Cancer Hospital Jinan China
The First Affiliated Hospital of Nanchang University Nanchang China
Fudan University Shanghai Cancer Center Shanghai China
Shengjing Hospital of China Medical University Shenyang China
The First Affiliated Hospital of Soochow University Suzhou China
Tianjin Medical University Cancer Institute & Hospital Tianjin China
Henan Cancer Hospital Zhengzhou China

On this site

📄 Adcetris (brentuximab vedotin) drug profile → 📄 Deltasone (prednisone) drug profile →

More Takeda trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05673785 on ClinicalTrials.gov ↗ ← All trials in China