Tokyo, Aug. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058584) titled 'Evaluation for the efficacy and safety of G-CSF in patients with diffuse large B-cell lymphoma: Observational study' on Aug. 1.
Study Type:
Observational
Primary Sponsor:
Institute - RAD-AR
Condition:
Condition - diffuse large B-cell lymphoma
Classification by malignancy - Malignancy
Genomic information - NO
Objective:
Narrative objectives1 - To confirm the effect of G-CSF administrations on the occurrence of febrile neutropenia after the first cycle of R-CHOP therapy and the change of the second cycle of R-CHOP therapy in patients with newly diagnosed diffuse large B-cell lymphoma using a Japanese real-world database.
Basic objectives2 - Safety,Efficacy
Eligibility:
Age-lower limit - Not applicable
Age-upper limit - Not applicable
Gender - Male and Female
Key inclusion criteria - - Hospitalized for DLBCL.
- Initiated R-CHOP therapy.
Key exclusion criteria - - G-CSF were used between hospitalization for DLBCL and initiation of R-CHOP therapy.
- Did not have follow-up period for outcomes.
- R-CHOP therapy was initiated within 30 days prior to hospitalization for DLBCL.
Target Size - 2000
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 04 Month 24 Day
Date of IRB - 2021 Year 07 Month 01 Day
Anticipated trial start date - 2025 Year 04 Month 24 Day
Last follow-up date - 2025 Year 08 Month 29 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066986
Disclaimer: Curated by HT Syndication.
