Non-Hodgkin's Lymphoma, Burkitt'sPhase 4NCT02585947
To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma
A Phase 4 study testing Tenofovir in people with Non-Hodgkin's Lymphoma, Burkitt's, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective… Read more about this study
- Who is it for?
- Ages 19 to 81 years
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Burkitt's
- What is being tested?
- Tenofovir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2015to Sep 2018
- Phase
- Phase 4
- 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 19 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age of ≥ 18 (Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy. / A woman of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of tenofovir. / If the Investigator obtains information concerning the pregnancy of a female patient, the Investigator must terminate the study drug immediately in that patient, and report the information to IRB in the same manner as for SAE reporting)
- CD 20 positive patients with Non-Hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and A. ECOG performance status 0-2 B. Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L) C. Adequate hematological function: hemoglobin ≥ 9g/dL, absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma D. Expected residual life ≥ 6 months
- Serum HBsAg negative, anti-HCV negative, but anti-HBc positive
- ALT < 80IU/mL, serum bilirubin < 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome
- Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent
Who cannot join
- Child-Pugh class C
- Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease
- Patient who has hypersensitivity to study drug
- Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Patient who is pregnant or on lactating. Or who has plans for pregnant or lactation during study period even the partner of the male patient
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University
Seoul, ASI|KR|KS013
About this study
Official title: A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy
The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.
Read the detailed description
This study will be conducted in a randomized, open-label, multi-center design. On Day 1 of chemotherapy, approximately 90 subjects screened and determined eligible will be randomized to either Group A or Group B in a 1:1 manner for study participation.
- Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
- Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 12 months (48 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
- Conditions
- Non-Hodgkin's Lymphoma, Burkitt's
- Being tested
- Tenofovir
- Keywords
- Non-Hodgkin's Lymphoma, Tenofovir
- Medical subject headings
- Burkitt Lymphoma, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TenofovirDrug
Also called Viread
Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).
| Study group | Role | What they receive |
|---|---|---|
| tenofovir for 24 weeks | Experimental | * prophylactic (preemptive) treatment
* 300mg for 24 weeks
* once daily Receives: Drug: Tenofovir |
| tenofovir for 48 weeks | Experimental | * prophylactic (preemptive) treatment
* 300mg for 48 weeks
* once daily Receives: Drug: Tenofovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV reactivation: defined as an increase in HBV DNA at least 10 folds from nadir or reappearance of HBsA or HBeAg in blood during treatment.
Measured: after 48 week from the End of treatment
Secondary outcomes (1)
Hepatitis flare: defined as elevation of HBV viral load more than 2,000IU/ml from the baseline or by the reappearance of HBsAg and elevation of ALT at least 100IU/ml from the baseline.
Measured: after 48 week from the End of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startNov 2015
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Hodgkin's Lymphoma, Burkitt'sStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences, Konkuk University Hospital
- Responsible party
- Principal investigator, Yoon Jun Kim, Seoul National University Hospital
- Investigators
- Yoon Jun Kim, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02585947
- Sponsor's protocol ID
- TenoCore
- Status last verified
- Dec 2016
- First submitted
- 22 Oct 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Jang H, Yu SJ, Lee HG, Kim TM, Lee YB, Cho EJ, Lee JH, Yoon JH, Kim YJ. Efficacy of Antiviral Prophylaxis up to 6 or 12 Months From Completion of Rituximab in Resolved Hepatitis B Patients: A Multicenter, Randomized Study. J Korean Med Sci. 2023 Jul 17;38(28):e216. doi: 10.3346/jkms.2023.38.e216.
PubMed 37463687
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma Patients With Isolated Anti-HBc-positivity Who Will be Treated With Rituximab Based Chemotherapy
- ClinicalTrials.gov ID
- NCT02585947
- Acronym / sponsor ID
- TenoCore
- Conditions
- Non-Hodgkin's Lymphoma, Burkitt's
- Keywords
- Non-Hodgkin's Lymphoma, Tenofovir
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Gilead Sciences, Konkuk University Hospital
- Study start
- Nov 2015
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 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.
The objective of this study is to analyze factors affecting Hepatitis B Virus (HBV) reactivation in anti-HBc positive patients with Non-Hodgkin's lymphoma treated with rituximab and compare HBV reactivation rates by duration of prophylactic treatment with tenofovir to contribute to the establishment of an effective prevention strategy.
Detailed description
This study will be conducted in a randomized, open-label, multi-center design. On Day 1 of chemotherapy, approximately 90 subjects screened and determined eligible will be randomized to either Group A or Group B in a 1:1 manner for study participation.
- Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 6 months (24 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
- Group A: Upon the EOC, subjects will receive tenofovir 300mg for approximately 12 months (48 weeks) and undergo treatment and follow-up every 12 weeks for up to 72 weeks post chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tenofovir for 24 weeks | Experimental | Drug: Tenofovir* prophylactic (preemptive) treatment * 300mg for 24 weeks * once daily |
| tenofovir for 48 weeks | Experimental | Drug: Tenofovir* prophylactic (preemptive) treatment * 300mg for 48 weeks * once daily |
Who may qualify
- Ages
- 19 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age of ≥ 18 (Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study during screening to rule out pregnancy. / A woman of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 26 weeks after the last dose of tenofovir. / If the Investigator obtains information concerning the pregnancy of a female patient, the Investigator must terminate the study drug immediately in that patient, and report the information to IRB in the same manner as for SAE reporting)
- CD 20 positive patients with Non-Hodgkin's lymphoma who are planned to receive anticancer treatment with rituximab based chemotherapy and A. ECOG performance status 0-2 B. Adequate renal function: serum creatinine level < 2 mg/dL (177 μmol/L) C. Adequate hematological function: hemoglobin ≥ 9g/dL, absolute neutrophil count (ANC) ≥ 1,500/μL, platelet count ≥ 75,000/μL, unless abnormalities are due to bone marrow involvement by lymphoma D. Expected residual life ≥ 6 months
- Serum HBsAg negative, anti-HCV negative, but anti-HBc positive
- ALT < 80IU/mL, serum bilirubin < 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome
- Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent
Key exclusion criteria (5 listed)
- Child-Pugh class C
- Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease
- Patient who has hypersensitivity to study drug
- Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- Patient who is pregnant or on lactating. Or who has plans for pregnant or lactation during study period even the partner of the male patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TenofovirAlso: VireadAnti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC). | Drug | tenofovir for 24 weeks, tenofovir for 48 weeks |
Primary outcome
HBV reactivation: defined as an increase in HBV DNA at least 10 folds from nadir or reappearance of HBsA or HBeAg in blood during treatment.
Time frame: after 48 week from the End of treatment
1 secondary outcome
Hepatitis flare: defined as elevation of HBV viral load more than 2,000IU/ml from the baseline or by the reappearance of HBsAg and elevation of ALT at least 100IU/ml from the baseline.
Time frame: after 48 week from the End of treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2016.
- Derived from this study: PubMed 37463687Jang H, Yu SJ, Lee HG, Kim TM, Lee YB, Cho EJ, Lee JH, Yoon JH, Kim YJ. Efficacy of Antiviral Prophylaxis up to 6 or 12 Months From Completion of Rituximab in Resolved Hepatitis B Patients: A Multicenter, Randomized Study. J Korean Med Sci. 2023 Jul 17;38(28):e216. doi: 10.3346/jkms.2023.38.e216.
- Individual participant dataSharing planned: Undecided
Related trials for Non-Hodgkin's Lymphoma, Burkitt's
RecruitingPhase 1
In VIVO CAR-T Therapy for Relapsed/Refractory Hematological Malignancies
B-Acute Lymphoblastic Leukemia, B Cell Non-Hodgkin's Lymphoma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
RecruitingPhase 1
CLIC-2201 for the Treatment of Relapsed/Refractory B Cell Malignancies
B-Cell Leukemia, Non-Hodgkin's Lymphoma
Active, not recruitingPhase 1
Activated T Lymphocytes Expressing CARs, Relapsed CD19+ Malignancies Post-Allo HSCT(CARPASCIO)
Non-Hodgkin's Lymphoma, B-Cell ALL
Active, not recruitingPhase 1
Study of the Adverse Events and Change in Disease State of Pediatric Participants (and Young Adults Between the Ages of 18-25) With Relapsed/Refractory Aggressive Mature B-cell Neoplasms Receiving Subcutaneous (SC) Injections of Epcoritamab
Non-hodgkin Lymphoma
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.
Yoon Jun Kim, M.D., Ph.D. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tenofovir in people with Non-Hodgkin's Lymphoma, Burkitt's, run by Seoul National University Hospital at 1 site in South Korea.
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 5 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Yoon Jun Kim, M.D., Ph.D. (822-2072-3081, yoonjun@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV reactivation: defined as an increase in HBV DNA at least 10 folds from nadir or reappearance of HBsA or HBeAg in blood during treatment. (time frame: after 48 week from the End of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02585947, which also lists 1 linked publication.
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 21 Dec 2016.