Trial 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)
NCT ID:
NCT05673785
Condition:
Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Prednisone
Cyclophosphamide
Doxorubicin
Brentuximab Vedotin
Conditions: Keywords:
Drug Therapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Brentuximab Vedotin
Description:
Brentuximab vedotin IV infusion
Arm group label:
Brentuximab Vedotin + CHP
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Cyclophosphamide IV infusion
Arm group label:
Brentuximab Vedotin + CHP
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Doxorubicin IV infusion
Arm group label:
Brentuximab Vedotin + CHP
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Prednisone tablets
Arm group label:
Brentuximab Vedotin + CHP
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Beijing Cancer Hospital
Address:
City:
Beijing
Zip:
100142
Country:
China
Status:
Recruiting
Contact:
Last name:
Site Contact
Phone:
+8613683398726
Email:
songyq_vip@163.com
Investigator:
Last name:
Song Yuqin
Email:
Principal Investigator
Facility:
Name:
Peking University Third Hospital
Address:
City:
Beijing
Zip:
100191
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613661112910
Email:
bysyjhm@sina.com
Investigator:
Last name:
Jing Hongmei
Email:
Principal Investigator
Facility:
Name:
The First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613039046656
Email:
lbl2054@163.com
Investigator:
Last name:
Bai Ou
Email:
Principal Investigator
Facility:
Name:
West China Hospital, Sichuan University
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8618980601242
Email:
tingniu@sina.com
Investigator:
Last name:
Niu Ting
Email:
Principal Investigator
Facility:
Name:
Chongqing University Cancer Hospital
Address:
City:
Chongqing
Zip:
400030
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8615116296855
Email:
xqdoctor_li@163.com
Investigator:
Last name:
Li Jieping
Email:
Principal Investigator
Facility:
Name:
Fujian Medical University Union Hospital
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613809552722
Email:
doctorsjz@163.com
Investigator:
Last name:
Shen Jianzhen
Email:
Principal Investigator
Facility:
Name:
Guangdong Provincial Peoples Hospital
Address:
City:
Guangzhou
Zip:
510080
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613924196915
Email:
gcpliwy@126.com
Investigator:
Last name:
Li Wenyu
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Zhejiang University school of medicine
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8657187236898
Email:
jiej0503@163.com
Investigator:
Last name:
Jin Jie
Email:
Principal Investigator
Facility:
Name:
Anhui Provincial Cancer Hospital
Address:
City:
Hefei
Zip:
230088
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8618900518383
Email:
dingkaiy@126.com
Investigator:
Last name:
Ding Kaiyang
Email:
Principal Investigator
Facility:
Name:
Shandong Cancer Hospital
Address:
City:
Jinan
Zip:
250117
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613642138692
Email:
zengjunli@163.com
Investigator:
Last name:
Li Zengjun
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Nanchang University
Address:
City:
Nanchang
Zip:
330006
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613970038386
Email:
691058841@qq.com
Investigator:
Last name:
Li Fei
Email:
Principal Investigator
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+862164175590
Phone ext:
8904
Email:
hkutao@hotmail.com
Investigator:
Last name:
Tao Rong
Email:
Principal Investigator
Facility:
Name:
Shengjing Hospital of China Medical University
Address:
City:
Shenyang
Zip:
110022
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8618940251012
Email:
sjyangw@163.com
Investigator:
Last name:
Yang Wei
Email:
Principal Investigator
Facility:
Name:
The First Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Zip:
215004
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613862553199
Email:
jinzhengming519519@163.com
Investigator:
Last name:
Jin Zhengming
Email:
Principal Investigator
Facility:
Name:
Tianjin Medical University Cancer Institute & Hospital
Address:
City:
Tianjin
Zip:
300060
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613702031222
Email:
qzz@163.com
Investigator:
Last name:
Qian ZhengZi
Email:
Principal Investigator
Facility:
Name:
Henan Cancer Hospital
Address:
City:
Zhengzhou
Zip:
450003
Country:
China
Status:
Not yet recruiting
Contact:
Last name:
Site Contact
Phone:
+8613837169301
Email:
weixudong63@126.com
Investigator:
Last name:
Wei Xudong
Email:
Principal Investigator
Start date:
February 10, 2023
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Takeda
Agency class:
Industry
Source:
Takeda
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05673785
https://clinicaltrials.takeda.com/study-detail/a688e46576ec4dff?idFilter=%5B%22C25024%22%5D
