Tokyo, Oct. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059271) titled 'IMBRUVICA Capsules 140mg Specified drug-use survey in patients with WM/LPL' on Oct. 2.
Study Type:
Observational
Primary Sponsor:
Institute - Janssen Pharmaceutical K.K.
Condition:
Condition - primary Waldenstrom's macroglobulinemia / lymphoplasmacytic lymphoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To examine the safety of IMBRUVICA Capsules 140 mg (Hereinafter referred to as this drug) in patients with primary Waldenstrom's macroglobulinemia / lymphoplasmacytic lymphoma (WM/LPL) treated for the first time in clinical practice.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - Patients who treated IMBRUVICA Capsules for the first time for WM/LPL in accordance with the approved indication and dosage and administration
Key exclusion criteria - NA
Target Size - 82
Recruitment Status:
Recruitment status - Open public recruiting
Date of protocol fixation - 2022 Year 12 Month 23 Day
Date of IRB - 2022 Year 12 Month 23 Day
Anticipated trial start date - 2023 Year 02 Month 01 Day
Last follow-up date - 2028 Year 01 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057123
Disclaimer: Curated by HT Syndication.
