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NCT04856137Not yet recruitingPhase 1/2

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 · Last updated 23 Apr 2021 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Not yet recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
74 (estimated)
First submitted
26 Nov 2019
Start date
1 May 2021
Primary completion date
31 Dec 2023
Lead sponsor
National Health Research Institutes, Taiwan
NCT number
NCT04856137

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 74
  • From 1 May 2021 to the primary completion date, 31 Dec 2023
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
  • Grade III peripheral neuropathy secondary to prior to therapy

Other illness

  • Active or uncontrolled infection.
  • Known hypersensitivity to ruxolitinib or paclitaxel
  • Second malignancy, except indolent cancers not on active anti-cancer therapy.

Other

  • Pregnant or breast-feeding females.
  • Life expectancy \< 6 months
  • Patients with brain or leptomeningeal metastases.

Who the study is looking for

  • 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.
  • Patients must have recovered from toxic effects of all prior therapy before entering onto study.
  • A treatment of drug-free interval of at least 3 weeks since the last dose of chemotherapy is required.
  • More than 4 weeks since prior radiotherapy is required.
  • Adequate bone marrow function
  • Adequate renal function with calculated glomerular filtration rate \> 15 mL/min
  • Patients must have adequate liver function
  • All patients must sign a document of informed consent indicating their awareness of the investigational nature and the risks of the study.

Age in the registry: 20 years to 75 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.