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)
NCT ID: NCT05673785
Last Updated: 2025-07-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
52 participants
INTERVENTIONAL
2023-02-10
2027-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Brentuximab Vedotin + CHP
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.
Brentuximab Vedotin
Brentuximab vedotin IV infusion
Cyclophosphamide
Cyclophosphamide IV infusion
Doxorubicin
Doxorubicin IV infusion
Prednisone
Prednisone tablets
Interventions
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Brentuximab Vedotin
Brentuximab vedotin IV infusion
Cyclophosphamide
Cyclophosphamide IV infusion
Doxorubicin
Doxorubicin IV infusion
Prednisone
Prednisone tablets
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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Related Links
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To obtain more information on the study, click here/on this link
Other Identifiers
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C25024
Identifier Type: -
Identifier Source: org_study_id
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