Actively Recruiting
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Led by Sun Yat-sen University · Updated on 2024-10-22
39
Participants Needed
11
Research Sites
121 weeks
Total Duration
On this page
Sponsors
S
Sun Yat-sen University
Lead Sponsor
F
Fifth Affiliated Hospital, Sun Yat-Sen University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants aged 18 years or older, male or female
- Pathologically confirmed CD5-positive diffuse large B-cell lymphoma (DLBCL)
- At least one measurable or evaluable lesion according to Lugano 2014 lymphoma criteria
- Eastern Cooperative Oncology Group (ECOG) performance status score between 0 and 2
- Expected survival of at least 3 months
- Sufficient function of bone marrow, liver, and kidneys
- Participants able to understand the study and provide informed consent
You will not qualify if you...
- DLBCL combined with other lymphoma types or transformed DLBCL
- DLBCL with central nervous system invasion
- Previous treatment with BTK inhibitors
- Contraindications to any drugs used in the combined treatment
- Infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)
- Inability to swallow tablets or gastrointestinal diseases affecting drug absorption
- Pregnant or breastfeeding women, or those of childbearing age not willing to use contraception
- Mental illness or inability to provide informed consent
- Investigator judgment that the patient is unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
Guangzhou, China, China, 51000
Actively Recruiting
2
Gansu Cancer Hospital
Lanzhou, Gansu, China
Actively Recruiting
3
Dongguan People's Hospital
Dongguan, Guangdong, China, 510060
Actively Recruiting
4
Fifth Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510060
Actively Recruiting
5
First People's Hospital of Guangzhou
Guangzhou, Guangdong, China
Actively Recruiting
6
Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou, Guangdong, China
Actively Recruiting
7
Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
Actively Recruiting
8
First Affiliated Hospital of Shantou University Medical College.
Shantou, Guangdong, China
Actively Recruiting
9
Shenzhen People's Hospital
Shenzhen, Guangdong, China
Actively Recruiting
10
Zhaoqing First People's Hospital
Zhaoqing, Guangdong, China
Actively Recruiting
11
Fifth Affiliated Hospital of Sun Yat-sen University
Zhuhai, Guangdong, China, 510060
Actively Recruiting
Research Team
Q
Qingqing Cai, MD. PhD.
CONTACT
Y
Yi Xia, MD. PhD.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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