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

• Status: Not yet recruiting
• Trial end date: 2028-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Health Research Institutes, Taiwan
• Collaborators: Chang Gung Memorial Hospital; China Medical University Hospital; Shin Kong Wu Huo-Shih Memorial Hospital; Taipei Veterans General Hospital, Taiwan
• Treatments: Paclitaxel; Rituximab

Criteria

Inclusion Criteria:

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

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

3. Measurable disease

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

5. Patients must have recovered from toxic effects of all prior therapy before entering onto study.

6. A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.

7. More than 4 weeks since prior radiotherapy is required.

8. Adequate bone marrow function

9. Adequate renal function with calculated glomerular filtration rate > 15 mL/min

10. Patients must have adequate liver function

11. All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.

Exclusion Criteria:

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

2. Pregnant or breast-feeding females.

3. Active or uncontrolled infection.

4. Life expectancy < 6 months

5. Patients with brain or leptomeningeal metastases.

6. Known hypersensitivity to ruxolitinib or paclitaxel

7. Grade III peripheral neuropathy secondary to prior to therapy

8. Second malignancy, except indolent cancers not on active anti-cancer therapy.