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

Plain-language summary

This study evaluates the drug Orelabrutinib combined with the R-CHOP chemotherapy regimen in patients with CD5-positive diffuse large B-cell lymphoma (DLBCL). Adults aged 18 and over with pathologically confirmed CD5-positive DLBCL and measurable disease may take part. It is a Phase 2 study that is currently recruiting participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Recruiting

Sponsor

Sun Yat-sen University

Intervention

Orelabrutinib Oral Tablet, R-CHOP Protocol

Start date

11/1/2024

Estimated completion

3/1/2027

Countries

China

Related genes

Locations

• Guangzhou, China
• Lanzhou, China
• Dongguan, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Guangzhou, China
• Shantou, China
• Shenzhen, China
• Zhaoqing, China
• Zhuhai, China

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.