Status:
UNKNOWN
Antiviral Agent HARVONI® for the Treatment of HCV-associated Indolent B-Cell Lymphoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
Indolent Lymphoma
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
We and other investigators have revealed an association between Hepatitis C virus (HCV) seropositivity and an increased risk of developing marginal zone B-cell lymphoma (MZ), lymphoplasmacytic lymphom...
Detailed Description
Although several epidemiological studies, including our study have been demonstrated the link between HCV and B-cell non-Hodgkin's lymphoma (NHL), the direct evidence of the HCV-associated-NHL remains...
Eligibility Criteria
Inclusion
- Patients older than 18 years with histologically proven diagnoses of indolent B-cell NHLs and with positive genotype 1 or 2 HCV (non-cirrhotic status) were eligible.
- Indolent B-cell NHLs includes:
- Low-grade marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue (MALT) type: known as MALT lymphoma.
- Splenic marginal zone lymphomas (SMZL)
- Waldenström's macroglobulinemia (WM, known as lymphoplasmacytic lymphoma) .
- Grade 1, 2 follicular lymphoma (FL). 3 Stage I to III (modified Ann Arbor stage), and non-life threatening IV lymphoma. 4 Patients had not previously been treated with chemotherapy or immunotherapy, were eligible. 5 Patients with clinical, echographical, or radiological suspicion of lymphoma lesions were eligible.
Exclusion
- Evidence of histologic transformation to a high-grade lymphoma (such as grade 3 and 4 follicular lymphoma, and high-grade MALT lymphoma).
- Life-threatening disseminated lymphoma.
- Primary gastric lesions were not eligible.
- Prior diagnosis of neoplasm within 5 years, except cervical intraepithelial neoplasia type 1 (CIN1) or localized non-melanomatous skin cancer.
- Evidence of clinically significant cardiac disease, as defined by history of symptomatic ventricular arrhythmias, congestive heart failure or myocardial infarction within 12 months before study entry.
- Evidence of symptomatic central nervous system (CNS) disease.
- Evidence of active opportunistic infections.
- Liver cirrhosis B and C (Child-Pugh score)
- Known HIV infection.
- Pregnant or lactating status.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 15 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03261349
Start Date
September 1 2017
End Date
August 15 2021
Last Update
August 25 2017
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