Status:
UNKNOWN
Incidence of Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients
Lead Sponsor:
National Health Research Institutes, Taiwan
Collaborating Sponsors:
National Taiwan University Hospital
Mackay Memorial Hospital
Conditions:
Non-Hodgkin's Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a single-arm study. Key eligibility criteria include (1) newly diagnosed, diffuse large B-cell or follicular cell non-Hodgkin's lymphoma; (2) negative test for hepatitis B surface antigen (HBs...
Detailed Description
Treatment plan: A typical course of rituximab-CHOP chemotherapy is as follows: rituximab 375 mg/m2 i.v., day 1, cyclophosphamide 750 mg/m2 i.v., day 1, doxorubicin 50 mg/m2 i.v., day 1, vincristine ...
Eligibility Criteria
Inclusion
- Histologically proven diffuse large B-cell or follicular B-cell non-Hodgkin's lymphoma, for which chemotherapy with rituximab-CHOP chemotherapy is considered treatment-of-choice.
- Evidence of 'resolved' HBV infection. Eligible subjects must be negative for serum HBV surface antigen (HBsAg) and positive for anti-core antibody (anti-HBc).
- Age \>18 years.
- Performance status with ECOG score 0-2.
- No previous chemotherapy and radiotherapy, no concurrent glucocorticoid use.
- Absolute neutrophil count (ANC) \> 1,500/mm3, platelet \> 100,000/mm3 in the peripheral blood.
- Total bilirubin \< 2.5 mg/dl. Alanine aminotransferase (ALT) \< 3 times UNL (upper limits of normal range).
- Serum creatinine \< 1.5 mg/dl. 9.10.Life expectancy 3 months.
- Signed informed consent.
Exclusion
- Pregnant or breast-feeding women.
- Patients with history of brain metastasis or CNS involvement.
- Child's class B or C in patients with liver cirrhosis.
- Impaired cardiac function with NYHA (New York Heart Association) classification Gr II.
- History of other liver diseases such as hepatitis C, D, autoimmune hepatitis, primary biliary cirrhosis, Wilsons' disease.
- Other major systemic disease, such as active infection, significant cardiac disease, neurological deficit or psychiatric disorder, that the investigators consider to be significant risk.
- Any concomitant cancer treatment.
- Known hypersensitivity of any of the study drugs (rituximab, cyclophosphamide, vincristine, doxorubicin, and prednisolone).
- Known human immunodeficiency virus (HIV) infection.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT00931229
Start Date
June 1 2009
End Date
December 1 2017
Last Update
November 9 2016
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan