Chidamide in Patients With Recurrent and Refractory Diffuse Large b

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05690191
• Other study ID #: JD-LK-2021-095-02
• Status: Enrolling by invitation
• Start date: June 1, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: January 2023
• Source: Second Affiliated Hospital of Soochow University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 169
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

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

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complete response rate	Complete response rate	30 months
Other	Progression-free survival	Progression-free survival	30 months
Other	Overall survival time	Overall survival time	30 months
Primary	Objective response rate	Objective response rates assessed by the investigator	30 months
Secondary	Adverse Events	Incidence of adverse events	30 months