Clinical trial NCT02588560: Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy
Official title: Serial Viral Load Changes and Hepatotoxicity in Lymphoma Patients With Hepatitis C Antibody After Chemotherapy Treatment: A Prospective Multicenter Observational Study and Long-term Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma
Hepatitis C Antibodies
Drug Therapy
Keywords: lymphoma, hepatitis C virus, chemotherapy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 38
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lymphoma patient plus hepatitis C

Brief summary: In last few years, most researches about hepatic complication after chemotherapy focused on hepatitis B virus (HBV). With adequate prophylaxis and monitor, HBV-related hepatitis flares can be prevented. In contrast, cancer patients with hepatitis C virus (HCV) infection are traditionally considered as relative safe to receive chemotherapy. However, two large retrospective studies recently showed that severe hepatitis could develop in 14-27% lymphoma patients with chronic HCV infection, including 3-4% hepatic failure. The risk factors to predict severe hepatitis are pre-treatment elevated ALT level and liver cirrhosis. Due to the lack of prospective studies, the dynamic changes of serum HCV RNA levels and the association of hepatitis are still unclear.

Some epidemiologic studies demonstrated an association between HCV infection and B-cell lymphoma. Diffuse large B-cell lymphoma (DLBCL) is the most common lymphoma and several reports showed higher prevalence of HCV infection among DLBCL patients than the controls. HCV infected DLBCL patients are reported to have distinct clinical characteristics, such as older, more with elevated LDH levels, and more with extra-nodal involvement. Regarding the impact of HCV infection on prognosis, the results are conflicting. Taiwan is an endemic area of HCV but there are limited reports addressing the clinical characteristics and prognosis in this unique population.

Therefore, the investigators initiate a prospective, multi-center observational study to clarify the dynamic association between serum HCV RNA levels and hepatitis in HCV-infected lymphoma patients treated with chemotherapy.


Eligibility criteria: Inclusion Criteria:

1. Newly diagnosed histologically proven malignant lymphoma
2. Eligible subjects must be positive for anti-HCV Ab
3. Age ≥ 20 years
4. Planned to receive chemotherapy
5. No recent chemotherapy and radiotherapy in the past one year. Pre-enrollment steroids for symptomatic relief are allowed but less than equivalent dose to prednisolone total 140 mg
6. Left expectancy ≥ 3 months
7. Signed informed consent
8. ECOG 0-2

Exclusion Criteria:

1. Patients not willing to receive chemotherapy
2. Chronic hepatitis B infection (positive for HBsAg), but those with resolved HBV infection (positive for anti-HBc and negative for HBsAg) are allowed
3. Other major systemic diseases, such as active infection, significant cardiac disease, neurologic deficit or psychiatric disorders, that the investigators consider to be at significant risk
4. Known human immunodeficiency virus (HIV) infection
5. Pregnant or breast-feeding woman

Primary outcomes:
measure: Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
timeFrame: one year
measure: Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
timeFrame: one year
measure: Interval (months) between Peak HCV RNA Level and Hepatitis
timeFrame: one year
measure: Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
timeFrame: one year
Secondary outcomes:
measure: Number of Participants with Hepatitis after Chemotherapy
timeFrame: one year
measure: Number of Participants with Severe Hepatitis after Chemotherapy
timeFrame: one year
measure: Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
timeFrame: one year
measure: Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
timeFrame: one year
Other outcomes:
Locations:
Study officials:
References: