An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy With Tenofovir in HBsAg-positive Patients With Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED Study)

July 15, 2018 updated by: Yonsei University
An Observational Study on Evaluating the Efficacy and Safety of Preemptive Antiviral Therapy with Tenofovir in HBsAg-positive Patients with Diffuse Large B-cell Lymphoma Receiving Rituximab-CHOP Chemotherapy (SPEED study)

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

112

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Do young Kim, MD
  • Phone Number: 82-2-2228-1992
  • Email: DYK1025@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
        • Sub-Investigator:
          • Do Young Kim, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Previously untreated Diffuse Large B-cell Lymphoma (DLBCL) with HBsAg (+) who are suitable for receiving R-CHOP chemotherapy

Description

Inclusion Criteria:

  • Males or females aged more than18
  • HBsAg-positive DLBCL patients (it is possible to enrol the patients with combined DLBCL and low grade lymphoma such as follicular lymphoma)
  • Previously untreated DLBCL patients who are suitable for receiving R-CHOP chemotherapy
  • Serum ALT no more than 2 x ULN (including normal ALT)
  • Life expectancy 6 months
  • A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are no more than 1 years after the onset of menopause.
  • Informed consent

Exclusion Criteria:

  • Other subtype of lymphoma except DLBCL
  • DLBCL patients who are NOT suitable for receiving R-CHOP chemotherapy OR plan to receive other chemotherapy
  • patients had been treated with antiviral therapy known to have activity against HBV (e.g., alpha-interferon, lamivudine, telbivudine, clevudine, adefovir, entecavir or tenofovir) within the previous 6 months.
  • evidence of hepatocellular carcinoma.
  • evidence of decompensated liver disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage number of patients with hepatitis due to HBV reactivation
Time Frame: 2 years (every 3 months)

Percentage number of patients with hepatitis due to HBV reactivation during the preemptive tenofovir therapy and for 24 weeks after withdrawal from tenofovir.

Definition;

  • Hepatitis was defined as a more than 3-fold increase of serum ALT on 2 consecutive determinations at least 5 days apart.
  • Hepatitis was defined to be due to HBV reactivation when it was preceded or accompanied by an increase of serum HBV DNA to more than 10 times that of the pre-exacerbation baseline and the serum HBV DNA turned from negative to positive.
2 years (every 3 months)
Percentage number of patients with hepatitis due to Safety assessment
Time Frame: 2 years (every 3 months)
Safety assessment; NCI CTCAE v 4.0 and tolerability evaluation - drug compliance
2 years (every 3 months)
Chemotherapy disruption due to hepatitis
Time Frame: 2 years (every 3 months)
Chemotherapy disruption due to hepatitis: defined as either premature termination or delay of more than 8 days between chemotherapy cycles.
2 years (every 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2015

Primary Completion (ANTICIPATED)

March 1, 2021

Study Completion (ANTICIPATED)

March 1, 2021

Study Registration Dates

First Submitted

January 11, 2015

First Submitted That Met QC Criteria

January 29, 2015

First Posted (ESTIMATE)

February 3, 2015

Study Record Updates

Last Update Posted (ACTUAL)

July 17, 2018

Last Update Submitted That Met QC Criteria

July 15, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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