Combining orelabrutinib with R-CHOP for treating CD5-positive DLBCL

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase II clinical trial evaluates the efficacy and safety of orelabrutinib in combination with the R-CHOP regimen for patients with untreated CD5-positive diffuse large B-cell lymphoma (DLBCL). Participants will undergo 6 cycles of treatment with orelabrutinib added from the second cycle, followed by 2 additional cycles of rituximab and orelabrutinib. The primary endpoint of the trial is the 2-year event-free survival rate. This multicenter study aims to provide insights into a potentially effective first-line treatment for this specific patient population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Universitiy Cancer Center, Sun Yat-Sen University,
  Guangzhou, China, China Recruiting
• Gansu Cancer Hospital
  Lanzhou, Gansu, China Recruiting
• Dongguan People's Hospital
  Dongguan, Guangdong, China Recruiting
• Fifth Affiliated Hospital of Guangzhou Medical University
  Guangzhou, Guangdong, China Recruiting
• First People's Hospital of Guangzhou
  Guangzhou, Guangdong, China Recruiting
• Guangdong Provincial Hospital of Traditional Chinese Medicine
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Qingqing Cai, MD. PhD.
• Email: caiqq@sysucc.org.cn
• Phone: 02087342823

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Orelabrutinib plus Pola-R-CHP as first-line treatment for intermediate- to high-risk DLBCL

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.