Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy

Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02588560
• Other study ID #: 103-7486B
• Status: Enrolling by invitation
• Phase: N/A
• First received: October 16, 2015
• Last updated: October 26, 2015
• Start date: September 2015
• Est. completion date: August 2019

Study information

• Verified date: August 2015
• Source: Chang Gung Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: National Science Council
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 38
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Therapy
• Hepatitis
• Hepatitis C
• Hepatitis C Antibodies
• Lymphoma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy		one year	Yes
Primary	Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy		one year	Yes
Primary	Interval (months) between Peak HCV RNA Level and Hepatitis		one year	Yes
Primary	Increase (log) of HCV Viral Load between Baseline and after Chemotherapy		one year	Yes
Secondary	Number of Participants with Hepatitis after Chemotherapy	Hepatitis is defined as ALT level > 2.5X ULN	one year	Yes
Secondary	Number of Participants with Severe Hepatitis after Chemotherapy	Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN	one year	Yes
Secondary	Number of Participants with Chemotherapy Interruption due to Hepatotoxicity		one year	Yes
Secondary	Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity		one year	Yes