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

Primary Purpose

Non-Hodgkin's Lymphoma, Burkitt's

Status

Unknown status

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Tenofovir

About this trial

This is an interventional prevention trial for Non-Hodgkin's Lymphoma, Burkitt's focused on measuring Non-Hodgkin's Lymphoma, Tenofovir

Eligibility Criteria

19 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Seoul National UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

tenofovir for 24 weeks

tenofovir for 48 weeks

Arm Description

prophylactic (preemptive) treatment 300mg for 24 weeks once daily

prophylactic (preemptive) treatment 300mg for 48 weeks once daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02585947

First Posted

October 22, 2015

Last Updated

December 20, 2016

Sponsor

Seoul National University Hospital

Collaborators

Gilead Sciences, Konkuk University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02585947

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

November 2015 (undefined)

Primary Completion Date

June 2018 (Anticipated)

Study Completion Date

September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

Collaborators

Gilead Sciences, Konkuk University Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non-Hodgkin's Lymphoma, Burkitt's

Keywords

Non-Hodgkin's Lymphoma, Tenofovir

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

tenofovir for 24 weeks

Arm Type

Experimental

Arm Description

prophylactic (preemptive) treatment 300mg for 24 weeks once daily

Arm Title

tenofovir for 48 weeks

Arm Type

Experimental

Arm Description

prophylactic (preemptive) treatment 300mg for 48 weeks once daily

Intervention Type

Drug

Intervention Name(s)

Tenofovir

Other Intervention Name(s)

Viread

Intervention Description

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).

Primary Outcome Measure Information:

Title

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 Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yoon Jun Kim, M.D., Ph.D.

Phone

822-2072-3081

yoonjun@snu.ac.kr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yoon Jun Kim, M.D., Ph.D.

Organizational Affiliation

Seoul National University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Seoul National University

City

Seoul

ZIP/Postal Code

ASI|KR|KS013

Country

Korea, Republic of

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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