Incidence of Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients
This study is ongoing, but not recruiting participants.
Sponsor:
National Health Research Institutes, Taiwan
Collaborators:
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Information provided by (Responsible Party):
National Health Research Institutes, Taiwan
ClinicalTrials.gov Identifier:
NCT00931229
First received: June 29, 2009
Last updated: December 6, 2011
Last verified: December 2011
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Purpose
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 (HBsAg) and positive for antibody to hepatitis B core antigen (anti-HBc); (3) adequate bone marrow, liver, and kidney function. All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines. The primary endpoint of this study is the incidence of hepatitis B virus (HBV) reactivation, defined by a greater than 10-fold increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy and within 1 year after completion of the last course of rituximab-CHOP chemotherapy. Patients who have HBV reactivation during the study period will receive free entecavir treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks. The secondary endpoints include the incidence of hepatitis flare, defined as a greater than 3 fold increase of serum alanine aminotransferase (ALT) level that exceeded 100 IU/L, and the efficacy and safety of rituximab-CHOP chemotherapy.
| Condition | Intervention |
|---|---|
|
Non-Hodgkin's Lymphoma |
Drug: entecavir |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Incidence of Hepatitis B Reactivation in Non-Hodgkin's Lymphoma Patients Who Receive Rituximab-containing Chemotherapy and Are Previously Infected With Hepatitis B Virus |
Resource links provided by NLM:
Drug Information available for:
Entecavir
Rituximab
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by National Health Research Institutes, Taiwan:
Primary Outcome Measures:
- enroll 150 patients [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 150 |
| Study Start Date: | June 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: entecavir
All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines.
|
Drug: entecavir
All eligible patients will receive rituximab-CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) chemotherapy according to current treatment guidelines. The primary endpoint of this study is the incidence of HBV reactivation, defined by a greater than 10-fold increase, compared with previous nadir levels, of HBV DNA during rituximab-CHOP chemotherapy and within 1 year after completion of the last course of rituximab-CHOP chemotherapy. Patients who have HBV reactivation during the study period will receive free entecavir treatment, one of the standard treatment for chronic hepatitis B, for 48 weeks.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
11.Signed informed consent.
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00931229
Locations
| Taiwan | |
| National Taiwan University Hospital | |
| Taipei, Taiwan | |
Sponsors and Collaborators
National Health Research Institutes, Taiwan
National Taiwan University Hospital
Mackay Memorial Hospital
China Medical University Hospital
Chi Mei Medical Hospital
Taichung Veterans General Hospital
Kaohsiung Veterans General Hospital.
Kaohsiung Medical University
Investigators
| Study Director: | Tsang-Wu Liu, Ph.D | National Health Research Institutes, Taiwan |
More Information
No publications provided
| Responsible Party: | National Health Research Institutes, Taiwan |
| ClinicalTrials.gov Identifier: | NCT00931229 History of Changes |
| Other Study ID Numbers: | T1408 |
| Study First Received: | June 29, 2009 |
| Last Updated: | December 6, 2011 |
| Health Authority: | Taiwan: Department of Health |
Keywords provided by National Health Research Institutes, Taiwan:
|
hepatitis B reactivation |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Lymphoma Lymphoma, Non-Hodgkin Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Neoplasms by Histologic Type |
Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Rituximab Entecavir Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Antirheumatic Agents Therapeutic Uses Antineoplastic Agents Antiviral Agents Anti-Infective Agents |
ClinicalTrials.gov processed this record on June 18, 2013