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 After 4 cycles of BCL regimen, patients demonstrating stable disease(SD) or progressive disease (PD) will be withdrawn from the study.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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
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;
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;
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
RECRUITINGComplete response rate(CRR)
The rate of patients who achieved CR after 4 cycles of bendamustine combined with chidamide and lenalidomide therapy (BCL regimen).
Time frame: At the end of 4 cycles of BCL regimen (each cycle is 28 days)
Main adverse events
The safety and tolerability of the BCL regimen measured by the major adverse events.
Time frame: From enrollment to 1 month after the end of last patient's treatment
Overall response rate(ORR)
The rate of patients who achieved CR or PR after treatment of 4 cycles of BCL regimen
Time frame: 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.
Time frame: 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.
Time frame: From enrollment to 2 years after the last patient's treatment
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Maintenance therapy period (2 years) Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.;