Chidamide in Patients With Recurrent and Refractory Diffuse Large b

Sponsor

Second Affiliated Hospital of Soochow University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05690191

Collaborator

(none)

169

Enrollment

Location

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Diffuse Large B-cell Lymphoma	Drug: Chidamide Drug: Lenalidomide Drug: Rituximab

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 Design

Study Type:

Observational

Anticipated Enrollment :

169 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2026

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Chidamide in combination with rituximab and 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	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

Arm

Intervention/Treatment

Chidamide in combination with rituximab and 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

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

Outcome Measures

Primary Outcome Measures

Objective response rate [30 months]
Objective response rates assessed by the investigator

Secondary Outcome Measures

Adverse Events [30 months]
Incidence of adverse events

Other Outcome Measures

Complete response rate [30 months]
Complete response rate
Progression-free survival [30 months]
Progression-free survival
Overall survival time [30 months]
Overall survival time

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Soochow University	Suzhou	Jiangsu	China

Sponsors and Collaborators

Second Affiliated Hospital of Soochow University

Investigators

Principal Investigator: Bingzong LI, Second Affiliated Hospital of Soochow University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital of Soochow University

ClinicalTrials.gov Identifier:

NCT05690191

Other Study ID Numbers:

JD-LK-2021-095-02

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 19, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lymphoma

Lymphoma, B-Cell

Lymphoma, Large B-Cell, Diffuse

Rituximab

Lenalidomide

Study Results

No Results Posted as of Jan 19, 2023