Trial Title:
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
NCT ID:
NCT06647940
Condition:
Diffuse Large B Cell Lymphoma (DLBCL)
Conditions: Official terms:
Lymphoma, Large B-Cell, Diffuse
Tyrosine Kinase Inhibitors
Conditions: Keywords:
DLBCL
Orelabrutinib
CD5-positive
R-CHOP
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:
Orelabrutinib Oral Tablet
Description:
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
Arm group label:
Orelabrutinib in combination with R-CHOP
Other name:
Bruton's Tyrosine Kinase Inhibitor
Intervention type:
Drug
Intervention name:
R-CHOP Protocol
Description:
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Arm group label:
Orelabrutinib in combination with R-CHOP
Other name:
R-CHOP regimen
Summary:
This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the
efficacy and safety of orelabrutinib combined with the R-CHOP (rituximab,
cyclophosphamide, vincristine, doxorubicin, and prednisone) regimen as first-line
treatment in CD5-positive diffuse large B-cell lymphoma (DLBCL) patients.
Detailed description:
The purpose of this phase II clinical trial is to evaluate the efficacy and safety of
orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients.
The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP
(orelabrutinib added from the second cycle), followed by 2 cycles of rituximab +
orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if
the response is assessed as complete remission (CR), maintenance therapy with
orelabrutinib will be conducted.
The primary endpoint is the 2-year event-free survival (EFS) rate.
Criteria for eligibility:
Criteria:
Key Inclusion Criteria:
1. Subjects fully understand and voluntarily participate in this study and sign
informed consent.
2. Aged ≥18 years, both male and female.
3. Pathologically confirmed CD5-positive DLBCL
4. There must be at least one measurable or evaluable lesion that meets the evaluation
criteria for Lugano 2014 lymphoma.
5. Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
6. Expected survival ≥3 months.
7. Sufficient bone marrow, liver, and kidney function.
Key Exclusion Criteria:
1. DLBCL combined with other types of lymphoma. Transformed DLBCL.
2. DLBCL with central nervous system invasion.
3. The patients had previously received BTK inhibitors.
4. The patients have contraindications to any drug in the combined treatment.
5. Patients with the infection of human immunodeficiency virus (HIV) and/or acquired
immunodeficiency syndrome.
6. Inability to swallow tablets, presence of malabsorption syndrome, or any other
gastrointestinal disease or dysfunction that may affect the absorption of the study
drug.
7. Pregnant and lactating women, and subjects of childbearing age who do not want to
use contraception.
8. Mentally ill persons or persons unable to obtain informed consent.
9. The investigators think that the patient is not suitable for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Gansu Cancer Hospital
Address:
City:
Lanzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Junfeng Jiang
Phone:
13893332604
Email:
jiangjunfeng@gsszlyy.cn
Facility:
Name:
Dongguan People's Hospital
Address:
City:
Dongguan
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Yirong Jiang
Phone:
13688967985
Email:
13688967985@org.cn
Facility:
Name:
Fifth Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Runhui Zheng
Phone:
13560225061
Email:
332520646@qq.com
Facility:
Name:
First People's Hospital of Guangzhou
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Tingfen Deng
Phone:
13642689191
Email:
1255608195@qq.com
Facility:
Name:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuanbin Wu
Phone:
13711454979
Email:
wyb@gdhtcm.org.cn
Facility:
Name:
Second Affiliated Hospital of Guangzhou Medical University
Address:
City:
Guangzhou
Country:
China
Status:
Recruiting
Contact:
Last name:
Xu Ye
Phone:
13060669127
Email:
yexu@gzhmu.edu.cn
Facility:
Name:
First Affiliated Hospital of Shantou University Medical College.
Address:
City:
Shantou
Country:
China
Status:
Recruiting
Contact:
Last name:
Yongzhong Su
Phone:
18038865106
Email:
fuyiyuanban@163.com
Facility:
Name:
Shenzhen People's Hospital
Address:
City:
Shenzhen
Country:
China
Status:
Recruiting
Contact:
Last name:
Jihao Zhou
Phone:
18718678693
Email:
2568341625@qq.com
Facility:
Name:
Zhaoqing First People's Hospital
Address:
City:
Zhaoqing
Country:
China
Status:
Recruiting
Contact:
Last name:
Wei Lin
Phone:
13822658301
Email:
1222567198@qq.com
Facility:
Name:
Fifth Affiliated Hospital of Sun Yat-sen University
Address:
City:
Zhuhai
Zip:
510060
Country:
China
Status:
Recruiting
Contact:
Last name:
Nan Chen
Phone:
13631270598
Email:
chennan9@mail.suysu.edu.cn
Facility:
Name:
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Address:
City:
Guangzhou
Zip:
51000
Country:
China
Status:
Recruiting
Contact:
Last name:
Qing qing Cai, MD. PhD.
Phone:
0086-20-87342823
Email:
caiqq@sysucc.org.cn
Contact backup:
Last name:
Yi Xia, MD. PhD.
Phone:
0086-20-87342823
Email:
xiayi@sysucc.org.cn
Contact backup:
Last name:
Qingqing Cai, MD. PhD.
Contact backup:
Last name:
Yi Xia, MD. PhD.
Start date:
November 1, 2024
Completion date:
March 1, 2027
Lead sponsor:
Agency:
Sun Yat-sen University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital, Sun Yat-Sen University
Agency class:
Other
Collaborator:
Agency:
Gansu Cancer Hospital
Agency class:
Other
Collaborator:
Agency:
First Affiliated Hospital of Shantou University Medical College
Agency class:
Other
Collaborator:
Agency:
Southern Medical University, China
Agency class:
Other
Collaborator:
Agency:
Guangdong Provincial Hospital of Traditional Chinese Medicine
Agency class:
Other
Collaborator:
Agency:
Second Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Fifth Affiliated Hospital of Guangzhou Medical University
Agency class:
Other
Collaborator:
Agency:
Shenzhen People's Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou First People's Hospital
Agency class:
Other
Collaborator:
Agency:
Dongguan People's Hospital
Agency class:
Other
Collaborator:
Agency:
The First People's Hospital of Zhaoqing
Agency class:
Other
Source:
Sun Yat-sen University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06647940
