Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients（Rocket Trial）
Orelabrutinib in Combination with R-CHOP for CD5-positive DLBCL Patients: a Single-arm, Multicenter, Phase II Clinical Trial（Rocket Trial）
Sun Yat-sen University
39 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- Subjects fully understand and voluntarily participate in this study and sign informed consent.
- Aged ≥18 years, both male and female.
- Pathologically confirmed CD5-positive DLBCL
- There must be at least one measurable or evaluable lesion that meets the evaluation criteria for Lugano 2014 lymphoma.
- Eastern Cooperative Oncology Group(ECOG) performance status score of 0-2.
- Expected survival ≥3 months.
- Sufficient bone marrow, liver, and kidney function.
Exclusion Criteria9
- DLBCL combined with other types of lymphoma. Transformed DLBCL.
- DLBCL with central nervous system invasion.
- The patients had previously received BTK inhibitors.
- The patients have contraindications to any drug in the combined treatment.
- Patients with the infection of human immunodeficiency virus (HIV) and/or acquired immunodeficiency syndrome.
- Inability to swallow tablets, presence of malabsorption syndrome, or any other gastrointestinal disease or dysfunction that may affect the absorption of the study drug.
- Pregnant and lactating women, and subjects of childbearing age who do not want to use contraception.
- Mentally ill persons or persons unable to obtain informed consent.
- The investigators think that the patient is not suitable for the study.
Interventions
Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06647940