Status:
NOT_YET_RECRUITING
A Phase I/II Study of Diffuse Large B-cell Lymphoma
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
Taipei Veterans General Hospital, Taiwan
Chang Gung Memorial Hospital
Conditions:
Refractory Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
20-75 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This is an open-label, single arm, prospective, multiple-center phase Ib/II study. In phase Ib, a maximum of 18 patients will be enrolled in the dose-finding period to determine the RP2D, dependent o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patients who have prior treatment with ruxolitinib or taxane for DLBCL.
- Pregnant or breast-feeding females.
- Active or uncontrolled infection.
- Life expectancy \< 6 months
- Patients with brain or leptomeningeal metastases.
- Known hypersensitivity to ruxolitinib or paclitaxel
- Grade III peripheral neuropathy secondary to prior to therapy
- Second malignancy, except indolent cancers not on active anti-cancer therapy.
Key Trial Info
Start Date :
May 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT04856137
Start Date
May 1 2021
End Date
December 31 2028
Last Update
April 23 2021
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