A Phase II trial of DA-EPOCH And Rituximab with HD-MTX therapy for newly-diagnosed DLBCL with CD5 expression (PEARL5 study)

Phase 2

• Conditions: CD5-positive diffuse large B-cell lymphoma

• Registration Number: JPRN-UMIN000008507
• Lead Sponsor: CD5+ DLBCL Treatment Study Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-07-25
• Study Completion: 2020-11-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 47

Inclusion Criteria

Not provided

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
2-year progression-free survival rate

Secondary Outcome Measures

Name	Time	Method
Complete response rate, overall response rate, overall survival, 2-year CNS recurrence rate, adverse events