PEARL5 study

JRCT ID: jRCTs041180159

Registered date:29/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: CD5-positive diffuse large B-cell lymphoma
• Date of first enrollment: 30/11/2012
• Target sample size: 45
• Study type: Interventional
• Intervention(s): Four cycles of DA-EPOCH-R followed by 2 cycles of HD-MTX(3.5 g/m2 IV, day1, q2w) and additional 4 cycles of DA-EPOCH-R

Outcome(s)

• Primary Outcome: 2-year progression-free survival rate
• Secondary Outcome: Complete response rate, overall response rate, overall survival, 2-year CNS recurrence rate, adverse events

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Yamaguchi Motoko
• Source(s) of Monetary Support: Japan Agency for Medical Research and Development,Mie University Hospital
• Secondary ID(s): UMIN000008507