NCT05351346

Genotype-guided Treatment in DLBCL

A Study Comparing the Efficacy and Safety of Genotype-guided R-CHOP-X Versus R-CHOP in Patients With Diffuse Large B-Cell Lymphoma

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,100 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A multicenter, prospective, randomized, open-label, controlled trial to evaluate the efficacy and safety of genotype-guided targeted agents plus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP-X) versus rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in patients with diffuse large B-cell lymphoma

Conditions

• Diffuse Large B Cell Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Cyclophosphamide	Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Doxorubicin	Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Vincristine	Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
DRUG	Prednisone	Prednisone PO will be administered as per the schedule specified in the respective arm.
DRUG	Orelabrutinib	Orelabrutinib PO will be administered as per the schedule specified in the respective arm.
DRUG	Lenalidomide	Lenalidomide PO will be administered as per the schedule specified in the respective arm.
DRUG	Decitabine	Decitabine IV infusion will be administered as per the schedule specified in the respective arm.

Timeline

• Start date: 2022-06-01
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2022-04-28
• Last updated: 2023-03-24

Locations

1 site across 1 country: China