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NOT YET RECRUITING
NCT04856137
PHASE1/PHASE2

A Phase I/II Study of Diffuse Large B-cell Lymphoma

Sponsor: National Health Research Institutes, Taiwan

View on ClinicalTrials.gov

Summary

For continuous variables, mean, median, minimum, and maximum will be used for the descriptive purpose. For categorical variables, frequency and percentage will be used for descriptive statistics. The variables of OS will be estimated by the Kaplan-Meier method. Differences between groups will be calculated using the log-rank test for univariate analysis. Cox's proportional hazards model will be employed to test independent prognostic factors. All calculations will be performed using the Statistical Package of Social Sciences software, version 17.0 (SPSS, Inc., Chicago, IL, USA). The level of statistical significance will be set at 0.05 for all tests.

Official title: A Phase I/II Study of Relapse/Refractory Diffuse Large B-cell Lymphoma

Key Details

Gender

All

Age Range

20 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

74

Start Date

2021-05-01

Completion Date

2028-12-31

Last Updated

2021-04-23

Healthy Volunteers

No

Interventions

DRUG

Rituximab Paclitaxel Ruxolitinib

Rituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)