Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy

October 26, 2015 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

38

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Lymphoma patient plus hepatitis C

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
HCV lymphoma patients with chemotherapy
Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
Time Frame: one year
one year
Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
Time Frame: one year
one year
Interval (months) between Peak HCV RNA Level and Hepatitis
Time Frame: one year
one year
Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Hepatitis after Chemotherapy
Time Frame: one year
Hepatitis is defined as ALT level > 2.5X ULN
one year
Number of Participants with Severe Hepatitis after Chemotherapy
Time Frame: one year
Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN
one year
Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
Time Frame: one year
one year
Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

August 1, 2019

Study Registration Dates

First Submitted

October 16, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Estimate)

October 28, 2015

Last Update Submitted That Met QC Criteria

October 26, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103-7486B

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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