NCT05690191

Chidamide in Patients With Recurrent and Refractory Diffuse Large b

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 169 (estimated)
• Sponsor: Second Affiliated Hospital of Soochow University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Multicenter, Prospective, Observational Clinical Protocol for Chidamide in Combination With Rituximab and Lenalidomide (cR2) in Real-world Practice in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma

Detailed description

This is a prospective, multicenter, observational investigator-initiated clinical study. The subjects were adults (18 years of age and older) diagnosed with relapsed/refractory diffuse large B-cell lymphoma who will begin cR2 therapy at the time of enrollment. Patients were required to complete a visit every 4 weeks, lasting 24 weeks from the first dosing of the study protocol. The first visit was considered an enrollment visit. The specific dosage of cR2 will be determined according to the standard clinical practice of the treating physician. Participation in the study did not affect treatment decisions. Patients who could not continue with the cR2 regimen would terminate the visit early and then withdraw from the study. According to the data collected from the experiment, the safety and effectiveness of the research scheme were analyzed.

Conditions

• Diffuse Large B-cell Lymphoma

Interventions

Type	Name	Description
DRUG	Chidamide	Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses
DRUG	Lenalidomide	Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to day 21 of each cycle
DRUG	Rituximab	Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day of each cycle

Timeline

• Start date: 2021-06-01
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2023-01-19
• Last updated: 2023-01-19

Locations

1 site across 1 country: China