Radioimmunotherapy with 177Lu-DOTA-RITUXIMAB in B-cell lymphoma
- Conditions
- CD20-positive B-cell Lymphoma.Small cell B-cell lymphomaC83.0
- Registration Number
- IRCT20210612051548N4
- Lead Sponsor
- Boushehr University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
Histologically confirmed relapsed or refractory CD20-positive B-cell lymphoma
Age greater than 18 years
Life expectancy more than 3 months
Notpregnant or lactating women
Performance status of 2 or better according to the World Health Organization scale.
Absolute neutrophil count above1.5 × 109/L, a circulating lymphocyte count below 5 × 109/L, a platelet count above 100 · 109/L, a total bilirubin level of no more than 20 mmol/L, an alanine aminotransferase level below 2.5 times normal, and a serum creatinine clearance level above 60 mL/min.
Signed informed consent form
Patients who had previously undergone radiation therapy to the pelvis, femora, or lumbar spine or high-dose treatment with stem cell transplantation.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients with toxicity. Timepoint: weekly up to week 10 or until recovery from nadir. Method of measurement: Blood chemistry, hematology, and urine analysis.;The proportion of patients who have a partial, stable (not-progressed), or complete response to therapy. Timepoint: 8-12 weeks after treatment. Method of measurement: 18F-FDG PET/CT.
- Secondary Outcome Measures
Name Time Method