Chidamide in Patients With Recurrent and Refractory Diffuse Large b

• Conditions: Diffuse Large B-cell Lymphoma
• Interventions: Drug: Chidamide; Drug: Lenalidomide; Drug: Rituximab

• Registration Number: NCT05690191
• Lead Sponsor: Second Affiliated Hospital of Soochow University

Brief 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.

Study Timeline

• Study Start: 2021-06-01
• Study First Submitted: 2022-12-05
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-09
• Last Update Submitted: 2023-01-09
• Study First Posted: 2023-01-19
• Last Update Posted: 2023-01-19
• Primary Completion: 2026-08-01
• Study Completion: 2026-08-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

1. The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
2. Age 18 and above, no gender limitation;
3. Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
4. Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
5. The serum pregnancy test of female subjects of childbearing age was negative;
6. Understand the test procedure and content, and sign the informed consent voluntarily.

Exclusion Criteria

1. The decision of treating physicians to make cR2 regimen was not related to whether they participated in the study or not;
2. Age 18 and above, no gender limitation;
3. Patients with pathologically confirmed diffuse large B-cell lymphoma (DLBCL) who have relapsed or failed to respond to at least one systemic therapy;
4. Have at least one measurable lesion: any length of lymph node lesion ≥1.5cm or any length of extrinsic lesion > 1cm;
5. The serum pregnancy test of female subjects of childbearing age was negative;
6. Understand the test procedure and content, and sign the informed consent voluntarily.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Objective response rate	30 months	Objective response rates assessed by the investigator

Secondary Outcome Measures

Name	Time	Method
Adverse Events	30 months	Incidence of adverse events

Trial Locations

Locations (1)

Second Affiliated Hospital of Soochow University; 🇨🇳 Suzhou, Jiangsu, China