Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07072221

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

Led by The First Affiliated Hospital of Soochow University · Updated on 2025-07-18

40

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older, any gender
  • Ability to understand and provide written informed consent
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 3
  • Expected survival time of more than 3 months
  • Diagnosis of peripheral T-cell lymphoma confirmed by pathology according to 2022 WHO classification
  • Measurable lesions at least 15 mm in diameter by PET/CT
  • Relapsed or refractory PTCL after at least one prior systemic therapy, with no prior treatment using chidamide, lenalidomide, or bendamustine
  • Non-blood related side effects from prior treatments resolved to Grade 1 or better, except hair loss
  • Adequate organ function including: cardiac ejection fraction ≥ 50%, asymptomatic arrhythmia; liver enzymes ≤ 2 times upper normal limit; bilirubin less than 2 times upper normal limit; renal clearance ≥ 80 mL/min; oxygen saturation > 90% without oxygen support; lung function tests ≥ 50% predicted
  • Adequate bone marrow function: hemoglobin ≥ 9 g/dL; platelets ≥ 70 x 10^9/L (or ≥ 50 x 10^9/L if bone marrow involved); neutrophils ≥ 1.0 x 10^9/L (or ≥ 0.75 x 10^9/L if bone marrow involved); CD34+ cells ≥ 2.0 x 10^9/kg
  • Willingness to use contraception during the study and follow-up
  • Good compliance with study procedures
Not Eligible

You will not qualify if you...

  • Previous treatment with chidamide, lenalidomide, or bendamustine, or other anti-tumor therapy within 4 weeks
  • Participation in another clinical study within 4 weeks
  • HIV infection or active hepatitis B or C infection
  • Uncontrolled active infections
  • Severe liver or kidney dysfunction (enzymes or creatinine > 3 times upper limit of normal)
  • Serious heart disease or severe arrhythmia causing symptoms or abnormal heart function (NYHA class 2 or higher)
  • Presence of other tumors requiring treatment
  • History of vascular embolism
  • Pregnant or breastfeeding women
  • Severe immune suppression
  • Psychiatric conditions that prevent consent or participation
  • Unlikely to complete all study visits and procedures or not meeting study participation requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215006

Actively Recruiting

Loading map...

Research Team

Z

Zhengming Jin

CONTACT

C

Changju Qu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here