To hear about similar clinical trials, please enter your email below
Trial Title:
Chidamide in Patients With Recurrent and Refractory Diffuse Large b
NCT ID:
NCT05690191
Condition:
Diffuse Large B-cell Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Rituximab
Lenalidomide
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Drug
Intervention name:
Chidamide
Description:
Chidamide tablets: 20mg orally, twice a week (at least 3 days between doses
Arm group label:
Chidamide in combination with rituximab and lenalidomide
Intervention type:
Drug
Intervention name:
Lenalidomide
Description:
Lenalidomide capsule: 25mg orally, once before going to bed every night, from day 1 to
day 21 of each cycle
Arm group label:
Chidamide in combination with rituximab and lenalidomide
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Rituximab injection: 375mg/m2 intravenously, once every 4 weeks (Q4w), on the first day
of each cycle
Arm group label:
Chidamide in combination with rituximab and lenalidomide
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.
Criteria for eligibility:
Study pop:
Diffuse Large B-cell Lymphoma
Sampling method:
Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Second Affiliated Hospital of Soochow University
Address:
City:
Suzhou
Country:
China
Start date:
June 1, 2021
Completion date:
August 1, 2026
Lead sponsor:
Agency:
Second Affiliated Hospital of Soochow University
Agency class:
Other
Source:
Second Affiliated Hospital of Soochow University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05690191
