Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05182957

Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Led by The First Affiliated Hospital of Soochow University · Updated on 2026-05-01

31

Participants Needed

1

Research Sites

336 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aim of this study will evaluate the Efficacy and Safety of Anti-PD-1 monoclonal antibody Combined Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma Patients.

CONDITIONS

Official Title

Clinical Study on Anti-PD-1 Plus Lenalidomide and Azacitidine in Relapsed/Refractory Peripheral T-cell Lymphoma

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Confirmed relapsed or refractory Peripheral T-cell Lymphoma with measurable lesions larger than 1.5 cm
  • Disease status includes less than 50% reduction after prior treatments, progression after first-line therapy, or new/increased lesions after stem cell transplant
  • Age 18 years or older
  • ECOG performance status of 2 or less
  • Adequate organ function including specific blood counts, heart function (LVEF ≥50%), liver enzymes, kidney function (CR or CCr ≥60 ml/min), lung function (Level 1 or less), no significant dyspnea, and oxygen saturation above 91%
  • Willingness to use birth control during the study and for one year after
  • Estimated survival of at least 3 months
  • Voluntary signing of informed consent
Not Eligible

You will not qualify if you...

  • Major surgery within 4 weeks before starting treatment
  • Previous other malignancies except cured tumors without active lesions for 3 years or certain treated skin and tonsil cancers
  • Failed previous allogeneic hematopoietic stem cell transplantation
  • Stroke or brain hemorrhage within the last 3 months
  • Serious heart disease (NYHA class 3 or 4), recent heart attack within 6 months, uncontrolled arrhythmias, or serious lung disease
  • HIV infection or active hepatitis B or C
  • Uncontrolled systemic infections
  • Pregnancy or breastfeeding
  • Any life-threatening disease or organ dysfunction that may risk safety or interfere with treatment absorption or study results as judged by researchers

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Actively Recruiting

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Research Team

C

Caixia Li, M.D

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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