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RECRUITING
NCT07072221
NA

Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory PTCL Patients

Sponsor: The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

To evaluate the efficacy and safety of bendamustine combined with chidamide and lenalidomide in R/R PTCL patients.

Official title: A Prospective, Exploratory Clinical Study of Bendamustine Combined With Chidamide and Lenalidomide for Relapsed and Refractory Peripheral T-cell Lymphoma Patients

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2024-11-01

Completion Date

2029-11-01

Last Updated

2025-07-18

Healthy Volunteers

No

Interventions

DRUG

BCL regimen

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;

PROCEDURE

Cohort 1 (ASCT-eligible)

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;

DRUG

Cohort 2 (ASCT--ineligible)

Maintenance therapy period (2 years) Chidamide; Specification: 5mg per tablet; 15mg biw for 2 weeks per 3 weeks, po.;

Locations (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China