LymphomaNCT02056548
Hepatitis B Virus Reactivation After Withdrawal of Preemptive Antiviral Therapy in Hematologic Malignancy
An observational study of Lymphoma and Chronic Hepatitis B, run by Seoul St. Mary's Hospital.
Trial summary
Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Chronic Hepatitis B
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Dec 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic hepatitis B patients who will be newly diagnosed as malignant lymphomas and receive standard chemotherapies at Seoul St. Mary's Hospital in Korea.
Who may be able to join
- 18 years old or older
- ECOG performance status 0, 1, 2
- Hodgkin's or Non-Hodgkins lymphomas according to the WHO 2008 classification
- Patients who received standard cytotoxic chemotherapies
- Patients who finished chemotherapy (duration not exceeded 6 months) or who will finish the planned chemotherapy
- Patients who achieved at least partial response and do not need further chemotherapy
- HBsAg (+) patients who received preemptive antiviral therapies
Who cannot join
- Anti-HCV Ab(+), HIV(+), or autoimmune hepatitis
- Complications due to uncompensated liver cirrhosis
- Child pugh score : 10 points or more
- Hepatocellular carcinoma
- Patients who finish the lymphoma treatments with only radiotherapy
About this study
Official title: Comparison of the Occurrence of HBV Reactivation According to the Duration of Preemptive Antiviral Therapy in Chronic Hepatitis B Virus Carriers Receiving Cancer Chemotherapy for Hematologic Diseases
Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Based on the study results, guidelines recommend that preemptive antiviral therapy should be maintained for at least 6 months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or longer after final chemotherapy without definite evidences, and this practice increases the medical expenditure a lot. Therefore, the investigators are going to find out the proper and safe duration of preemptive antiviral therapy which can be a good reference in the future practice.
Read the detailed description
HBV reactivation in cancer patients is important not only for directly affecting severe hepatic failure but also for delaying of the further cancer treatments which may cause reduction of overall survival. Thus the guidelines according to the previous studies and other follow-up of randomized studies revealed that patients with positive HbsAg should be administered with preemptive antiviral therapy at least 6 month or more.
However, ideal duration for preemptive antiviral therapy to suppress viral reactivation and withdrawal hepatitis is not clearly identified at present time. It is because previous data just dealt with the efficiency of preemptive antiviral therapy, but most of them did not analyze the outcomes after withdrawal of antiviral therapy. Frequent late-onset reactivation hepatitis in association with preemptive antiviral therapy is mainly due to drug-resistance or post-withdrawal manifestation. Drug-resistance was mainly associated with lamivudine which is now substituted by entecavir or tenofovir which produce lower incidence of resistance (< 1.2% at 6 years). Therefore, the only issue at present is withdrawal hepatitis which may be due to early cessation of the antiviral drug.
- Conditions
- Lymphoma, Chronic Hepatitis B
- Keywords
- preemptive antiviral treatment, lymphoma, chronic hepatitis B
- Medical subject headings
- Lymphoma, Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence rate of hepatitis B viral reactivation
Measured: within one year after cessation of the antiviral drug
Secondary outcomes (1)
Severity of reactivation of hepatitis B
Severity according to ALT (IU/L) level Mild : up to 5 times from upper normal limit Moderate : 5- 10 times from upper normal limit Severe : ALT > 300 IU/L or ≥ 10 times
Measured: within one year after cessation of anviral drugs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (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.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Ho, Yoon, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056548
- Sponsor's protocol ID
- CHSCTC-R01-HEPATO
- Status last verified
- Feb 2014
- First submitted
- 3 Feb 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Occurrence of HBV Reactivation According to the Duration of Preemptive Antiviral Therapy in Chronic Hepatitis B Virus Carriers Receiving Cancer Chemotherapy for Hematologic Diseases
- ClinicalTrials.gov ID
- NCT02056548
- Acronym / sponsor ID
- CHSCTC-R01-HEPATO
- Conditions
- Lymphoma, Chronic Hepatitis B
- Keywords
- preemptive antiviral treatment, lymphoma, chronic hepatitis B
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 6 Feb 2014 (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.
Previous studies dealt with patients who maintained antiviral drugs for 2 ~ 6 months after final chemotherapy and they revealed that many of the patients who stopped preemptive antiviral drug within 6 months experienced viral reactivation. Based on the study results, guidelines recommend that preemptive antiviral therapy should be maintained for at least 6 months. Nevertheless, many clinicians apply the preemptive antiviral drugs for 1~2 years or longer after final chemotherapy without definite evidences, and this practice increases the medical expenditure a lot. Therefore, the investigators are going to find out the proper and safe duration of preemptive antiviral therapy which can be a good reference in the future practice.
Detailed description
HBV reactivation in cancer patients is important not only for directly affecting severe hepatic failure but also for delaying of the further cancer treatments which may cause reduction of overall survival. Thus the guidelines according to the previous studies and other follow-up of randomized studies revealed that patients with positive HbsAg should be administered with preemptive antiviral therapy at least 6 month or more.
However, ideal duration for preemptive antiviral therapy to suppress viral reactivation and withdrawal hepatitis is not clearly identified at present time. It is because previous data just dealt with the efficiency of preemptive antiviral therapy, but most of them did not analyze the outcomes after withdrawal of antiviral therapy. Frequent late-onset reactivation hepatitis in association with preemptive antiviral therapy is mainly due to drug-resistance or post-withdrawal manifestation. Drug-resistance was mainly associated with lamivudine which is now substituted by entecavir or tenofovir which produce lower incidence of resistance (< 1.2% at 6 years). Therefore, the only issue at present is withdrawal hepatitis which may be due to early cessation of the antiviral drug.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic hepatitis B patients who will be newly diagnosed as malignant lymphomas and receive standard chemotherapies at Seoul St. Mary's Hospital in Korea.
Key inclusion criteria (7 listed)
- 18 years old or older
- ECOG performance status 0, 1, 2
- Hodgkin's or Non-Hodgkins lymphomas according to the WHO 2008 classification
- Patients who received standard cytotoxic chemotherapies
- Patients who finished chemotherapy (duration not exceeded 6 months) or who will finish the planned chemotherapy
Key exclusion criteria (5 listed)
- Anti-HCV Ab(+), HIV(+), or autoimmune hepatitis
- Complications due to uncompensated liver cirrhosis
- Child pugh score : 10 points or more
- Hepatocellular carcinoma
- Patients who finish the lymphoma treatments with only radiotherapy
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
Cumulative incidence rate of hepatitis B viral reactivation
Time frame: within one year after cessation of the antiviral drug
1 secondary outcome
Severity of reactivation of hepatitis B
Time frame: within one year after cessation of anviral drugs
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
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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 Chronic Hepatitis B, run by Seoul St. Mary's 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 7 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 6 Feb 2014. 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?
Cumulative incidence rate of hepatitis B viral reactivation (time frame: within one year after cessation of the antiviral drug). 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 6 Feb 2014.