Clinical trial · Interventional
A Phase I/II Study of Diffuse Large B-cell Lymphoma
A Phase I/II Study of Relapse/Refractory Diffuse Large B-cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Refractory Diffuse Large B-cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Rituximab Paclitaxel Ruxolitinib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- single arm
- description
- ruxolitinib, paclitaxel, and rituximab
- interventionNames
- Drug: Rituximab Paclitaxel Ruxolitinib
Primary outcomes (1)
- measure
- Primary Outcome Measure
- timeFrame
- 1 year
- description
- The tumor response will be assessed according to IWG Response Criteria.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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