Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.
This study will enroll relapsed/refractory (R/R) peripheral T-cell lymphoma (PTCL) patients aged over 18 years who have received at least one line of prior systemic therapy. Participants will receive combination therapy with bendamustine, chidamide, and lenalidomide (BCL regimen), with dose reduction for patients >70 years old. After 4 cycles of BCL regimen, patients demonstrating stable disease(SD) or progressive disease (PD) will be withdrawn from the study. Patients achieving partial remission(PR) or complete remission(CR) will receive another 2 cycles of BCL regimen followed by stratification treatment as followings:
Cohort 1 (ASCT-eligible): Responders will proceed to autologous stem cell transplantation (ASCT) consolidation
Cohort 2 (ASCT-ineligible): Responders will receive oral chidamide maintenance therapy (minimum 2 years or until progression/unacceptable toxicity)
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 (ASCT-eligible) | Experimental | Patients who achieved PR/CR after 6 cycles of BCL regimen and were eligible to ASCT will proceed to ASCT consolidation |
|
| Cohort 2 (ASCT-ineligible) | Experimental | Patients who achieved PR/CR after 6 cycles of BCL regimen and were ineligible to ASCT will receive oral chidamide maintenance therapy (minimum 2 years or until progression/unacceptable toxicity) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCL regimen | Drug | Induction therapy period (28 days*6) Bendamustine; Specification: 100mg per vial; 90mg/m2 d1-2, ivgtt.; for age≤70 years; 70mg/m2 d1-2, ivgtt.; for age>70 years; Chidamide; Specification: 5mg per tablet; 20mg biw for 2 weeks, po.; for age≤70 years; 15mg biw for 2 weeks, po.; for age>70 years; Lenalidomide Specification:10mg per tablet; 10mg qd d1-d21, po.; for age≤70 years; 10mg qd d1-d14, po.; for age>70 years; |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate(CRR) | The rate of patients who achieved CR after 4 cycles of bendamustine combined with chidamide and lenalidomide therapy (BCL regimen). | At the end of 4 cycles of BCL regimen (each cycle is 28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Main adverse events | The safety and tolerability of the BCL regimen measured by the major adverse events. | From enrollment to 1 month after the end of last patient's treatment |
| Overall response rate(ORR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhengming Jin | Contact | 67781856 | jinzhengming519519@163.com | |
| Changju Qu | Contact | 67781856 | qcj310@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Soochow University | Recruiting | Suzhou | Jiangsu | 215006 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Cohort 1 (ASCT-eligible) | Procedure | Autologous hematopoietic stem cell transplantation SEAM conditioning Simustine 250mg/m2 orally, d1; Etoposide 200mg/m2 intravenous infusion, d2-d5; Cytarabine 400mg/m2 intravenous infusion, d2-d5; Metformin 140mg/m2 intravenous infusion, d6; |
|
| Cohort 2 (ASCT--ineligible) | Drug | Maintenance therapy period (2 years) Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.; |
|
The rate of patients who achieved CR or PR after treatment of 4 cycles of BCL regimen
| At the end of 4 cycles of BCL regimen (each cycle is 28 days) |
| 2-year Overall survival(OS) | OS will be assessed from the start of the BCL treatment to the date of death or end of follow-up. | From enrollment to 2 years after the last patient's treatment |
| 2-year progression-free survival(PFS) | PFS will be assessed from the start of the BCL treatment to the date of progression, relapse, death or end of follow-up. | From enrollment to 2 years after the last patient's treatment |
| D009369 |
| Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |