PEARL5 study
- Conditions
- CD5-positive diffuse large B-cell lymphoma
- Registration Number
- JPRN-jRCTs041180159
- Lead Sponsor
- Yamaguchi Motoko
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 45
(1) Histologically confirmed CD5-positive diffuse large B-cell lymphoma according to the 2008 WHO classification
(2) Confirmed CD20-positive and CD5-positive by immunohistochemistry and/or flow cytometry
(3) Ann Arbor stage: II, III, or IV
(4) Lymphoma cell count in peripheral blood 14 days before registration >= 10,000/mm3
(5) Age: 20 to 75 years old
(6) PS (ECOG): 0-3
(7) No clinical symptoms of CNS involvement
(8) Measureable lesion present
(9) No prior chemotherapy, radiotherapy, and antibody therapy
(10) Adequate organ function
(11) Written informed consent
(1) History of angle-closure glaucoma
(2) Uncontrollable diabetes mellitus in spite of insulin therapy
(3) Uncontrollable hypertension
(4) Pleural effusion or ascites except for those with little amount
(5) Coronary artery disease under treatment; cardiomyopathy, heart failure, or arrhythmia treated with anti-arrhythmic
(6) HBs antigen positive
(7) HCV antibody positive
(8) HIV antibody positive
(9) Interstitial pneumonia, pulmonary fibrosis
(10) Severe infection
(11) Liver cirrhosis
(12) Other active malignancies; history of lymphoma, myelodysplastic syndrome, or leukemia
(13) Pregnant, possible pregnant, or breastfeeding woman
(14) Severe psychosis
(15) Under systemic corticosteroid therapy
(16) Considered as ineligible by attending physicians for other reasons
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method