Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Ruijin Hospital
Shanghai, Shanghai Municipality, China, 200020
Actively Recruiting
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
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