Back to resultsA Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in Chinese Participants With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
Primary Purpose
Lymphoma
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Brentuximab Vedotin
Cyclophosphamide
Doxorubicin
Prednisone
Sponsored by
About this trial
This is an interventional treatment trial for Lymphoma focused on measuring Drug Therapy
Eligibility Criteria
Inclusion Criteria: 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.) Absolute neutrophil count >1.5×10^9/liter (L). Platelet count ≥75×10^9/L (unless documented bone marrow involvement with lymphoma). Exclusion Criteria: 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). Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.
Sites / Locations
- Beijing Cancer HospitalRecruiting
- Peking University Third Hospital
- The First Hospital of Jilin University
- West China Hospital, Sichuan University
- Chongqing University Cancer Hospital
- Fujian Medical University Union Hospital
- Guangdong Provincial Peoples Hospital
- The First Affiliated Hospital of Zhejiang University school of medicine
- Anhui Provincial Cancer Hospital
- Shandong Cancer Hospital
- The First Affiliated Hospital of Nanchang University
- Fudan University Shanghai Cancer Center
- Shengjing Hospital of China Medical University
- The First Affiliated Hospital of Soochow University
- Tianjin Medical University Cancer Institute & Hospital
- Henan Cancer Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Brentuximab Vedotin + CHP
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
CR Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
CR rate by IRF assessment following the completion of study treatment is defined as the proportion of participants who have achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR is defined as disappearance of all evidence of disease.
1-Year Progression Free Survival (PFS) Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
1-Year Overall Survival (OS) Rate
The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.
ORR by IRF and Investigator Assessment per 2014 Lugano Classification
ORR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses are defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) by IRF and investigator assessment following the completion of study treatment.
CR Rate by IRF and Investigator Assessment per 2014 Lugano Classification
CR rate by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by IRF and investigator assessment following the completion of study treatment.
Time to Response (TTR) by IRF and Investigator Assessment per 2014 Lugano Classification
TTR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses=time from date of first study drug administration to date of first documented objective response(CR or PR) by IRF and investigator assessment following the completion of study treatment for responders.
1-Year PFS Rate by IRF and Investigator Assessment per 2014 Lugano Classification
The 1-year PFS rate by IRF and investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Duration of Response (DOR) by Investigator Assessment per 2014 Lugano Classification
DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Serum Antibody-drug Conjugate (ADC) Concentration
Plasma Monomethyl Auristatin E (MMAE) Concentration
Percentage of Participants who are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive, ADA Titer, and Neutralizing Antidrug Antibody (Nab) Negative and Positive
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05673785
Brief Title
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)
Official Title
A Phase 2, Single-Arm, Open-Label, Multicenter Study of Brentuximab Vedotin in Combination With Cyclophosphamide, Doxorubicin (Hydroxydaunorubicin), Prednisone (CHP) in the Frontline Treatment of Chinese Patients With CD30-Positive (CD30+) Peripheral T-Cell Lymphomas (PTCL)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Takeda
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Drug Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Brentuximab Vedotin + CHP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Brentuximab Vedotin
Intervention Description
Brentuximab vedotin IV infusion
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Cyclophosphamide IV infusion
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Intervention Description
Doxorubicin IV infusion
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
Prednisone tablets
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) by Independent Review Facility (IRF) Assessment per Revised Response Criteria for Malignant Lymphoma
Description
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.
Time Frame
Up to approximately 7 months
Title
Percentage of Participants who Experience at Least One Treatment Emergent Adverse Event (TEAE)
Description
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.
Time Frame
Up to approximately 7 months
Title
Percentage of Participants With Clinically Significant Laboratory Test Values
Description
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.
Time Frame
Up to approximately 7 months
Title
Percentage of Participants With Clinically Significant Vital Signs
Description
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.
Time Frame
Up to approximately 7 months
Secondary Outcome Measure Information:
Title
CR Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
Description
CR rate by IRF assessment following the completion of study treatment is defined as the proportion of participants who have achieved a CR by IRF assessment using the IWG Revised Response criteria following the completion of study treatment. CR is defined as disappearance of all evidence of disease.
Time Frame
Up to approximately 7 months
Title
1-Year Progression Free Survival (PFS) Rate by IRF Assessment per Revised Response Criteria for Malignant Lymphoma
Description
The 1-year PFS rate by IRF assessment using the IWG Revised Response criteria is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time Frame
Up to approximately 12 months
Title
1-Year Overall Survival (OS) Rate
Description
The 1-year OS rate is defined as the percentage of participants alive at 1 year. OS is defined as the time from the start of study treatment to the date of death due to any cause.
Time Frame
Up to approximately 12 months
Title
ORR by IRF and Investigator Assessment per 2014 Lugano Classification
Description
ORR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated computed tomography (CT) and positron emission tomography (PET)-based responses are defined as the percentage of participants who have achieved a complete response (CR) or partial response (PR) by IRF and investigator assessment following the completion of study treatment.
Time Frame
Up to approximately 7 months
Title
CR Rate by IRF and Investigator Assessment per 2014 Lugano Classification
Description
CR rate by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses is defined as the percentage of participants who have achieved a CR by IRF and investigator assessment following the completion of study treatment.
Time Frame
Up to approximately 7 months
Title
Time to Response (TTR) by IRF and Investigator Assessment per 2014 Lugano Classification
Description
TTR by IRF and investigator assessment per 2014 Lugano Classification, assessed by integrated CT and PET-based responses=time from date of first study drug administration to date of first documented objective response(CR or PR) by IRF and investigator assessment following the completion of study treatment for responders.
Time Frame
Up to approximately 7 months
Title
1-Year PFS Rate by IRF and Investigator Assessment per 2014 Lugano Classification
Description
The 1-year PFS rate by IRF and investigator assessment per 2014 Lugano Classification is defined as the percentage of participants alive and progression free at 1 year. PFS is defined as the time from the start of study treatment to the date of first documentation of PD, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time Frame
Up to approximately 12 months
Title
Duration of Response (DOR) by Investigator Assessment per 2014 Lugano Classification
Description
DOR by investigator assessment using the 2014 Lugano Classification criteria is defined as the time between the first documentation of objective tumor response (CR or PR) by investigator assessment and the first subsequent documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or PD, whichever occurs first.
Time Frame
Up to approximately 36 months
Title
Serum Antibody-drug Conjugate (ADC) Concentration
Time Frame
Preinfusion and at multiple time points (Up to 96 hours [Cycle 1]/168 hours [Cycle 2]) postinfusion; Preinfusion up to Cycle 8, each cycle = 21 days
Title
Plasma Monomethyl Auristatin E (MMAE) Concentration
Time Frame
Preinfusion and at multiple time points (Up to 96 hours [Cycle 1]/168 hours [Cycle 2]) postinfusion; Preinfusion up to Cycle 8, each cycle = 21 days
Title
Percentage of Participants who are Antidrug Antibodies (ADA) Negative, ADA Transiently and Persistently Positive, ADA Titer, and Neutralizing Antidrug Antibody (Nab) Negative and Positive
Time Frame
Preinfusion on Day 1 of each cycle up to Cycle 8, each cycle = 21 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.)
Absolute neutrophil count >1.5×10^9/liter (L).
Platelet count ≥75×10^9/L (unless documented bone marrow involvement with lymphoma).
Exclusion Criteria:
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).
Previous treatment with brentuximab vedotin or CD30 monoclonal antibody.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Takeda Contact
Phone
+1-877-825-3327
Email
medinfoUS@takeda.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Study Director
Organizational Affiliation
Takeda
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Cancer Hospital
City
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613683398726
Email
songyq_vip@163.com
First Name & Middle Initial & Last Name & Degree
Song Yuqin
Facility Name
Peking University Third Hospital
City
Beijing
ZIP/Postal Code
100191
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613661112910
Email
bysyjhm@sina.com
First Name & Middle Initial & Last Name & Degree
Jing Hongmei
Facility Name
The First Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130021
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613039046656
Email
lbl2054@163.com
First Name & Middle Initial & Last Name & Degree
Bai Ou
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618980601242
Email
tingniu@sina.com
First Name & Middle Initial & Last Name & Degree
Niu Ting
Facility Name
Chongqing University Cancer Hospital
City
Chongqing
ZIP/Postal Code
400030
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8615116296855
Email
xqdoctor_li@163.com
First Name & Middle Initial & Last Name & Degree
Li Jieping
Facility Name
Fujian Medical University Union Hospital
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613809552722
Email
doctorsjz@163.com
First Name & Middle Initial & Last Name & Degree
Shen Jianzhen
Facility Name
Guangdong Provincial Peoples Hospital
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613924196915
Email
gcpliwy@126.com
First Name & Middle Initial & Last Name & Degree
Li Wenyu
Facility Name
The First Affiliated Hospital of Zhejiang University school of medicine
City
Hangzhou
ZIP/Postal Code
310003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8657187236898
Email
jiej0503@163.com
First Name & Middle Initial & Last Name & Degree
Jin Jie
Facility Name
Anhui Provincial Cancer Hospital
City
Hefei
ZIP/Postal Code
230088
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618900518383
Email
dingkaiy@126.com
First Name & Middle Initial & Last Name & Degree
Ding Kaiyang
Facility Name
Shandong Cancer Hospital
City
Jinan
ZIP/Postal Code
250117
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613642138692
Email
zengjunli@163.com
First Name & Middle Initial & Last Name & Degree
Li Zengjun
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613970038386
Email
691058841@qq.com
First Name & Middle Initial & Last Name & Degree
Li Fei
Facility Name
Fudan University Shanghai Cancer Center
City
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+862164175590
Ext
8904
Email
hkutao@hotmail.com
First Name & Middle Initial & Last Name & Degree
Tao Rong
Facility Name
Shengjing Hospital of China Medical University
City
Shenyang
ZIP/Postal Code
110022
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8618940251012
Email
sjyangw@163.com
First Name & Middle Initial & Last Name & Degree
Yang Wei
Facility Name
The First Affiliated Hospital of Soochow University
City
Suzhou
ZIP/Postal Code
215004
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613862553199
Email
jinzhengming519519@163.com
First Name & Middle Initial & Last Name & Degree
Jin Zhengming
Facility Name
Tianjin Medical University Cancer Institute & Hospital
City
Tianjin
ZIP/Postal Code
300060
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613702031222
Email
qzz@163.com
First Name & Middle Initial & Last Name & Degree
Qian ZhengZi
Facility Name
Henan Cancer Hospital
City
Zhengzhou
ZIP/Postal Code
450003
Country
China
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Contact
Phone
+8613837169301
Email
weixudong63@126.com
First Name & Middle Initial & Last Name & Degree
Wei Xudong
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD Sharing 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.
IPD Sharing URL
https://vivli.org/ourmember/takeda/
Links:
URL
https://clinicaltrials.takeda.com/study-detail/a688e46576ec4dff?idFilter=%5B%22C25024%22%5D
Description
To obtain more information on the study, click here/on this link
Learn more about this trial
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)
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