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| Name | Class |
|---|---|
| Chipscreen Biosciences, Ltd. | INDUSTRY |
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To assess the efficacy and safety of Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in the Treatment of Relapsed or Refractory DLBCL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL | Experimental | Anti-PD-1 Antibody Plus Chidamide and Rituximab Regimen in Relapsed or Refractory DLBCL |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-PD-1 Antibody Plus Chidamide and Rituximab | Drug | Anti-PD-1 Antibody 200mg, ivd, D1, every 3 weeks Chidamide 30mg, po,D-1, 4, 8, 11, 15, 18, every 3 weeks Rituximab 375mg/m2, ivd, D1, every 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| complete response rate | 24 weeks | |
| Objective remission rate | 24 weeks | |
| Disease Control Rate | 24 weeks | |
| Partial Remission Rate | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | PFS was defined as time from study registration to first disease progression or death whichever occurred first, otherwise subject data were censored at time last known disease free | 2 years |
| Overall Survival |
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Inclusion Criteria:
Male or female patients: 60-75 years old.
Relapsed or Refractory patients
Histologically confirmed DLBCL with CD20 positive
ECOG physical condition score: 0-1 points for patients.
The patients must be with at least one evaluable or measurable lesion meeting LYRIC 2016 criteria.
Patients who had received at least 2 cycles of standard first-line rituximab regimens didn't obtain remission or relapsed after remission, or who were unable or unwilling to receive chemotherapy due to illness or severe chemotherapy toxicity.
Hematology values must be within the following limits at baseline:
Biochemical values must be within the following limits at baseline:
LVEF ≥50%, as determined by echocardiography.
Each subject (or their legally acceptable representative) must sigh an informed consent form (ICF) indicating that he or she understands the purpose of any procedures for the study and are willing to participate in the study.
Thyroid stimulating hormone (TSH) or free Thyroxine (FT4) or free Triiodothyronine (FT3) were within the normal range of ±10%.
Expected survival time ≥6 months.
No radiotherapy, chemotherapy, targeted therapy or hematopoietic stem cell transplantation within 4 weeks before medication.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huiqiang Huang, professor | Contact | 0086-13808885154 | huanghqsysucc@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Huiqiang Huang, professor | Sun Yat-sen University | Principal Investigator |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| D000069283 | Rituximab |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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OS was defined as time from study registration to death, and otherwise censored at time last known alive
| 2 years |
| Percentage of Participants With Adverse Events (AEs) | Number of participants with adverse events occurring up to 30 days after the last administration are evaluated and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.01 | Up to 30 days after the last cycle of per-protocol treatment and 90 days after last dose of anti-PD-1 antibody |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |