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

ConditionRefractory Diffuse Large B-cell Lymphoma
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age20-75
SponsorNational Health Research Institutes, Taiwan

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with relapsed/refractory CD20+ diffuse large B-cell lymphoma.

Age greater than 20 years and younger than 75 years old.

Measurable disease

Patients must have an ECOG performance status of less than or equal to 2.

Disqualifiers

Patients who have prior treatment with ruxolitinib or taxane for DLBCL.

Pregnant or breast-feeding females.

Active or uncontrolled infection.

Life expectancy < 6 months

Trial design

Design model

Single group

Treatments tested in this trial

  • Rituximab Paclitaxel Ruxolitinib

    Drug

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

Treatment groups

74 Participants
are divided into 1 treatment group
Group A: single armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Primary Outcome Measure

The tumor response will be assessed according to IWG Response Criteria.

Time frame
1 year

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Health Research Institutes, Taiwan

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Collaborator

Chang Gung Memorial Hospital

Collaborator

China Medical University Hospital

Collaborator

Shin Kong Wu Huo-Shih Memorial Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: