LymphomaNCT02588560
Viral Load Changes in Lymphoma Patients With HCV Infection After Chemotherapy
An observational study of Lymphoma and Hepatitis C Antibodies, run by Chang Gung Memorial Hospital.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lymphoma, Hepatitis C Antibodies, Drug Therapy
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Lymphoma patient plus hepatitis C
Who may be able to join
- Newly diagnosed histologically proven malignant lymphoma
- Eligible subjects must be positive for anti-HCV Ab
- Age ≥ 20 years
- Planned to receive chemotherapy
- 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
- Left expectancy ≥ 3 months
- Signed informed consent
- ECOG 0-2
Who cannot join
- Patients not willing to receive chemotherapy
- Chronic hepatitis B infection (positive for HBsAg), but those with resolved HBV infection (positive for anti-HBc and negative for HBsAg) are allowed
- 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
- Known human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding woman
About this study
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
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.
- Conditions
- Lymphoma, Hepatitis C Antibodies, Drug Therapy
- Keywords
- lymphoma, hepatitis C virus, chemotherapy
- Medical subject headings
- Lymphoma, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| HCV lymphoma patients with chemotherapy | Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
Measured: one year
Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
Measured: one year
Interval (months) between Peak HCV RNA Level and Hepatitis
Measured: one year
Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
Measured: one year
Secondary outcomes (4)
Number of Participants with Hepatitis after Chemotherapy
Hepatitis is defined as ALT level > 2.5X ULN
Measured: one year
Number of Participants with Severe Hepatitis after Chemotherapy
Severe hepatitis is defined as ALT level > 5X ULN or Bilirubin level > 3.0X ULN
Measured: one year
Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
Measured: one year
Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2019 (estimated)
- Study completionAug 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588560
- Sponsor's protocol ID
- 103-7486B
- Status last verified
- Aug 2015
- First submitted
- 16 Oct 2015
- Last updated
- 28 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02588560
- Acronym / sponsor ID
- 103-7486B
- Conditions
- Lymphoma, Hepatitis C Antibodies, Drug Therapy
- Keywords
- lymphoma, hepatitis C virus, chemotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2019 (estimated)
- Study completion
- Aug 2019 (estimated)
- First posted
- 28 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HCV lymphoma patients with chemotherapy | – | –Lymphoma patients who are positive for anti-HCV and are planning to receive chemotherapy for lymphoma |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Lymphoma patient plus hepatitis C
Key inclusion criteria (8 listed)
- Newly diagnosed histologically proven malignant lymphoma
- Eligible subjects must be positive for anti-HCV Ab
- Age ≥ 20 years
- Planned to receive chemotherapy
- 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
Key exclusion criteria (5 listed)
- Patients not willing to receive chemotherapy
- Chronic hepatitis B infection (positive for HBsAg), but those with resolved HBV infection (positive for anti-HBc and negative for HBsAg) are allowed
- 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
- Known human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy
Time frame: one year
Number of Participants with Detectable Viremia and Developing Hepatitis after Chemotherapy
Time frame: one year
Interval (months) between Peak HCV RNA Level and Hepatitis
Time frame: one year
Increase (log) of HCV Viral Load between Baseline and after Chemotherapy
Time frame: one year
4 secondary outcomes
Number of Participants with Hepatitis after Chemotherapy
Time frame: one year
Number of Participants with Severe Hepatitis after Chemotherapy
Time frame: one year
Number of Participants with Chemotherapy Interruption due to Hepatotoxicity
Time frame: one year
Number of Participants with Early Stop of Chemotherapy due to Hepatotoxicity
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphoma and Hepatitis C Antibodies, run by Chang Gung Memorial Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Increasing HCV RNA Level and Developing Hepatitis after Chemotherapy (time frame: one year). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2015.