A Phase I/II Study of Diffuse Large B-cell Lymphoma
- Sponsor
- National Health Research Institutes, Taiwan
- Study ID
- NCT04856137
- Phase
- PHASE1/PHASE2
- Status
- Not Yet Recruiting
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Conditions
- Refractory Diffuse Large B-cell Lymphoma
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Rituximab Paclitaxel Ruxolitinib — DRUGRituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)
Study Details
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.
Key Dates
- Start date
- May 1, 2021
- Status verified
- Mar 2021
- Primary completion
- Dec 31, 2023
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 74 participants (estimated)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: single armruxolitinib, paclitaxel, and rituximab
Primary Outcome Measure
Primary Outcome Measure [ Time Frame: 1 year ]
Central Contacts
- Chih-Cheng Chen, M.D. Ph.D.886-5-3621000
- Hui-Jen Tsai, M.D. Ph.D.886-6-7000123
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