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

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 arm
    ruxolitinib, paclitaxel, and rituximab

Primary Outcome Measure

Primary Outcome Measure [ Time Frame: 1 year ]

Central Contacts

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