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To Compare the Efficacy of a Prophylactic Use of Tenofovir by Duration for the Non-Hodgkin's Lymphoma

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ClinicalTrials.gov Identifier: NCT02585947
Recruitment Status : Unknown
Verified December 2016 by Yoon Jun Kim, Seoul National University Hospital.
Recruitment status was:  Recruiting
First Posted : October 26, 2015
Last Update Posted : December 21, 2016
Sponsor:
Collaborators:
Gilead Sciences
Konkuk University Hospital
Information provided by (Responsible Party):
Yoon Jun Kim, Seoul National University Hospital

Brief 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 prevention strategy.

Condition or disease Intervention/treatment Phase
Non-Hodgkin's Lymphoma, Burkitt's Drug: Tenofovir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2015
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : September 2018


Arm Intervention/treatment
Experimental: tenofovir for 24 weeks
  • prophylactic (preemptive) treatment
  • 300mg for 24 weeks
  • once daily
Drug: Tenofovir
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).
Other Name: Viread

Experimental: tenofovir for 48 weeks
  • prophylactic (preemptive) treatment
  • 300mg for 48 weeks
  • once daily
Drug: Tenofovir
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).
Other Name: Viread




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  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. [ Time Frame: after 48 week from the End of treatment ]


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Ages Eligible for Study:   19 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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)
  2. 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
  3. Serum HBsAg negative, anti-HCV negative, but anti-HBc positive
  4. ALT < 80IU/mL, serum bilirubin < 3.0mg/dL, unless abnormalities are due to liver involvement by lymphoma or tumor lysis syndrome
  5. Individuals who were given and understood detailed explanations about this study, voluntarily decided to participate in the study, and provided written informed consent

Exclusion Criteria:

  1. Child-Pugh class C
  2. Other chronic liver diseases such as autoimmune hepatitis or Wilson's disease
  3. Patient who has hypersensitivity to study drug
  4. Patient who has galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  5. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02585947


Contacts
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Contact: Yoon Jun Kim, M.D., Ph.D. 822-2072-3081 yoonjun@snu.ac.kr

Locations
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Korea, Republic of
Seoul National University Recruiting
Seoul, Korea, Republic of, ASI|KR|KS013
Sponsors and Collaborators
Seoul National University Hospital
Gilead Sciences
Konkuk University Hospital
Investigators
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Principal Investigator: Yoon Jun Kim, M.D., Ph.D. Seoul National University Hospital

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Responsible Party: Yoon Jun Kim, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02585947     History of Changes
Other Study ID Numbers: TenoCore
First Posted: October 26, 2015    Key Record Dates
Last Update Posted: December 21, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Yoon Jun Kim, Seoul National University Hospital:
Non-Hodgkin's Lymphoma
Tenofovir
Additional relevant MeSH terms:
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Burkitt Lymphoma
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Lymphoma, B-Cell
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents