NCT06647940

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）

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 39 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The purpose of this phase II clinical trial is to evaluate the efficacy and safety of orelabrutinib in combination with R-CHOP for untreated CD5-positive DLBCL patients. The induction phase consisted of 6 cycles of orelabrutinib in combination with R-CHOP (orelabrutinib added from the second cycle), followed by 2 cycles of rituximab + orelabrutinib, for a total of 8 treatment cycles. After 8 cycles of induction therapy, if the response is assessed as complete remission (CR), maintenance therapy with orelabrutinib will be conducted. The primary endpoint is the 2-year event-free survival (EFS) rate.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	Orelabrutinib Oral Tablet	Orelabrutinib (150 mg po D1-D21) is added from the second cycle of R-CHOP regimen
DRUG	R-CHOP Protocol	Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Timeline

• Start date: 2024-11-01
• Primary completion: 2026-11-01
• Completion: 2027-03-01
• First posted: 2024-10-18
• Last updated: 2024-10-22

Locations

11 sites across 1 country: China