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Clinical Trials in China / NCT06647940
Recruiting Phase 2

Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients(Rocket Trial)

NCT06647940 · tracked via the Priya Life Science China tracker
Sponsor
Sun Yat-sen University
Phase
Phase 2
Started
2024-11-01
Last updated
2024-10-22

Condition(s) studied

Diffuse Large B Cell Lymphoma (DLBCL)

Investigational drug(s) / intervention(s)

Orelabrutinib Oral TabletR-CHOP Protocol

Orelabrutinib Oral Tablet: Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen

R-CHOP Protocol: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University, Guangzhou China Recruiting
Gansu Cancer Hospital Lanzhou Gansu Recruiting
Dongguan People's Hospital Dongguan Guangdong Recruiting
Fifth Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
First People's Hospital of Guangzhou Guangzhou Guangdong Recruiting
Guangdong Provincial Hospital of Traditional Chinese Medicine Guangzhou Guangdong Recruiting
Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong Recruiting
First Affiliated Hospital of Shantou University Medical College. Shantou Guangdong Recruiting
Shenzhen People's Hospital Shenzhen Guangdong Recruiting
Zhaoqing First People's Hospital Zhaoqing Guangdong Recruiting
Fifth Affiliated Hospital of Sun Yat-sen University Zhuhai Guangdong Recruiting

More Sun Yat-sen University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06647940 on ClinicalTrials.gov ↗ ← All trials in China