Actively Recruiting

Phase 2
Age: 18Years - 75Years
All Genders
NCT05348213

Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma

Led by Ruijin Hospital · Updated on 2024-10-23

76

Participants Needed

1

Research Sites

158 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A single-center, open, single-arm clinical study of the efficacy and safety of a novel targeted agent in combination with R-ICE in the treatment of relapsed and refractory diffuse Large B-cell lymphoma.

CONDITIONS

Official Title

Novel Targeted Drugs Combined With R-ICE Regimen in Relapsed and Refractory Diffuse Large B-cell Lymphoma

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of diffuse large B-cell lymphoma confirmed by biopsy according to WHO classification (excluding primary central lymphoma and HIV-associated lymphoma)
  • Presence of evaluable lesions detected by PET/CT
  • Life expectancy longer than 3 months
  • Prior sufficient first-line anti-lymphoma therapy with no remission within 90 days or disease progression, and at least 2 weeks since last anti-lymphoma treatment
  • Age between 18 and 75 years, male or female
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2
  • No serious organ damage and meeting laboratory requirements within 7 days before treatment: neutrophils ≥1500/mm3; platelets ≥75,000/mm3; total bilirubin ≤2 times upper limit; AST and ALT ≤3 times upper limit; creatinine clearance ≥60 ml/min
  • No cardiac dysfunction
  • Agreement to effective contraception if of reproductive age
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women (breastfeeding women must agree not to breastfeed while taking pomalidomide)
  • Known hepatitis B or C infection or HIV infection
  • History of deep vein thrombosis or pulmonary embolism within past 12 months
  • Bone marrow failure with neutrophils <1500/mm3 or platelets <75,000/mm3 unless related to lymphoma
  • Significant heart disease including unstable angina, recent myocardial infarction, severe congestive heart failure, or low left ventricular ejection fraction
  • Lymphoma involving the central nervous system
  • Allergy to study drug ingredients
  • Recent major surgery within 3 weeks before treatment
  • History of organ transplantation
  • Other active malignancies except treated basal cell carcinoma, cervical carcinoma in situ, or malignancy in remission for at least 5 years
  • Severe infection
  • Substance abuse or medical, psychological, or social conditions interfering with study participation
  • Investigator assessment deeming subject unsuitable for the study

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

Ruijin Hospital

Shanghai, Shanghai Municipality, China, 200020

Actively Recruiting

Loading map...

Research Team

Z

ZHAO weili

CONTACT

X

XU pengpeng

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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