Status:
UNKNOWN
Bendamustine-based Combination Therapy for PCNSL
Lead Sponsor:
Chonnam National University Hospital
Conditions:
PCNSL
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
This pilot study will i) evaluate the efficacy and the safety of bendamustine-based combination chemotherapy and ii) investigate the pharmacokinetics (PK)of bendamustine in plasma and CSF when given a...
Detailed Description
A relatively high proportion of patients diagnosed with primary CNS lymphoma will experience recurrent disease, yet therapy options are limited in salvage therapy. Based on the demonstrated activity a...
Eligibility Criteria
Inclusion
- PCNSL of diffuse large B-cell lymphoma (DLBCL) with a CNS lesion by tissue biopsy
- Age ≥ 19 years old
- Relapsed or refractory PCNSL after frontline combined chemotherapy or radiation
- ECOG performance status 0-2
- Absolute neutrophil count ≥ 1000/uL
- Platelets ≥ 100,000/uL
- Total bilirubin ≤ 1.5 x ULN (upper limit of normal)
- Aspartate aminotransferase (AST) ≤ 3 x ULN
- Creatinine ≤ 2.0 x ULN
Exclusion
- PCNSL of other than DLBCL or T-cell lymphoma with a CNS lesion by tissue biopsy
- Any of the following: pregnant women, nursing women, men or women of childbearing potential who are unwilling to employ adequate contraception
- Uncontrolled infection
- Therapy with myelosuppressive chemotherapy or biologic therapy \< 21 days prior to registration
- Persistent toxicities ≥ grade 3 from prior chemotherapy or biologic therapy regardless of interval since last treatment
- History of thromboembolic episodes ≤ 3 months prior to registration
- Active hepatitis B or C with uncontrolled disease
- Active other malignancy requiring treatment that would interfere with the assessments of response of the lymphoma to protocol treatment
- Any severe and/or uncontrolled medical conditions or other conditions that could adversely impact their ability to participate in the study
- Major surgery ≤ 4 weeks prior to registration or have not recovered from side effects of such therapy
Key Trial Info
Start Date :
January 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 20 2019
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03392714
Start Date
January 20 2016
End Date
January 20 2019
Last Update
January 8 2018
Active Locations (1)
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1
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea, 519-809