Clinical trial NCT05690191: Chidamide in Patients With Recurrent and Refractory Diffuse Large b
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
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diffuse Large B-cell Lymphoma
Lead sponsor: Second Affiliated Hospital of Soochow University
Sponsor class: OTHER
First posted: 2023-01-19
Enrollment: 169
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Diffuse Large B-cell Lymphoma

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Objective response rate
timeFrame: 30 months
Secondary outcomes:
measure: Adverse Events
timeFrame: 30 months
Other outcomes:
measure: Complete response rate
timeFrame: 30 months
measure: Progression-free survival
timeFrame: 30 months
measure: Overall survival time
timeFrame: 30 months
Locations:
city: Suzhou
country: China
facility: Second Affiliated Hospital of Soochow University
state: Jiangsu
Study officials:
affiliation: Second Affiliated Hospital of Soochow University
name: Bingzong LI
role: PRINCIPAL_INVESTIGATOR
References: