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To evaluate the efficacy and safety of chidamide combined with brentuximab vedotin regimen for CD30 positive PTCL patients who are unfit for chemotherapy.
This study will enroll CD30-positive peripheral T-cell lymphoma (PTCL) patients who are ineligible for conventional chemotherapy. Participants will receive induction therapy with 3 cycles of BvC regimen (brentuximab vedotin plus chidamide combination). Patients demonstrating disease progression (PD) or stable disease (SD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive stratification consolidation therapy as followings:
Cohort 1 (patients achieved CR): Receive 3 additional cycles of BvC consolidation
Cohort 2 (patients achieved PR): Receive 6 additional cycles of BvC consolidation
After consolidation therapy, responding patients (CR/PR) will receive chidamide maintenance therapy for ≥2 years
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (patients achieved CR) | Experimental | Patients achieving CR after 3 cycles of BvC therapy will receive 3 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years |
|
| Cohort 2 (patients achieved PR) | Experimental | Patients achieving PR after 3 cycles of BvC therapy will receive 6 additional cycles of BvC consolidation followed by chidamide maintenance therapy for ≥2 years |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Induction therapy-3 cycles of BvC (Brentuximab vedotin plus Chidamide) | Drug | 3 cycles of BvC treatment for all enrolled patients. Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.; |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) | The rate of patients who achieved CR after 3 cycles of BvC regimen | At the end of 3 cycles of BvC (each cycle is 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Main adverse reactions | The safety and tolerability of the therapeutic regimen measured by the major adverse events. | From enrollment to 1 month after consolidation treatment of the last patient |
| 2-year overall survival(OS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin | Contact | 67781856 | jinzhengming519519@163.com | |
| Changju Qu | Contact | 67781856 | qcj310@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
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|
| Consolidation therapy- 3 or 6 cycles of BvC(Brentuximab vedotin plus chidamide) | Drug | Consolidation therapy( For patients who achieved CR after induction therapy, 3 cycles of additional BvC treatment; For patients who achieved PR after induction therapy, 6 cycles of additional BvC treatment). Brentuximab vedotin; Specification: 50mg per vial; 1.8mg/kg qd d1 every 3 weeks, ivgtt.; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks every 3 weeks, po.; Maintenance therapy chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years |
|
| Maintenance therapy-chidamide | Drug | Chidamide (20mg biw for 2 weeks every 3 weeks, po.) for ≥2 years |
|
OS will be assessed from the start of the combination regimen to the date of death or end of follow-up.
| From enrollment to 2 year after treatment of the last patient |
| Overall response rate(ORR) | The rate of patients who achieved CR or PR after 3 cycles of BvC regimen | At the end of 3 cycles of BvC (each cycle is 21 days) |
| 2-year progression-free survival(PFS) | PFS will be assessed from the first drug given to the date of progression, relapse, death or end of follow-up. | From enrollment to 2 year after treatment of the last patient |
| ID | Term |
|---|---|
| D000079963 | Brentuximab Vedotin |
| C547816 | N-(2-amino-5-fluorobenzyl)-4-(N-(pyridine-3-acrylyl)aminomethyl)benzamide |
| ID | Term |
|---|---|
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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