Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA

NCT04539119 | Unknown Phase 3 DMC

• 1 other identifier: EnTe-HBV
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, single-center, open-label, randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of HBV DNA positive B-cell lymphoma patients. This study plans to enroll about 120 participants in total. Recruitment will last for 2 years. The study visit will take place on the first day of each cycle of therapy until the end of the treatment. Participants who meet the inclusion/exclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. When the copy count of HBV DNA drops below 1\*10\^3/L, entecavir single agent will be given orally, until one year after the cycle of therapy. Treatment response will be evaluated routinely after chemotherapy or immunotherapy. Within 2 years after the last participant is enrolled, participants' survival information will collected by telephone and/or clinical visit every 3 months after the last visit (i.e. date and cause of death, subsequent cancer treatment, etc.), if there is no withdrawal of the informed consent form.

Conditions

B-cell Lymphoma; HBV

Outcome Measures

Primary Outcomes (1)

• The rate of successful HBV replication inhibition at cycle 2

  The rate of participants that the copy count of HBV DNA is lower than 1\*10\^3/L.

  At the start of cycle 2 (each cycle is 21-28 days)

Secondary Outcomes (5)

• Time to successful HBV replication inhibition

  During the intervention

• 2-year PFS

  2 years after enrollment

• 2-year OS

  2 years after enrollment

• Complete response rate

  After the completion of first-line chemotherapy, an average of 4 months from enrollment

• The incidence of adverse events

  From enrollment to study completion, an maximum of 3 years.

Other Outcomes (1)

• Associated factors for successful inhibition of HBV replication

  From enrollment to study completion, an maximum of 3 years.

Study Arms (2)

Entecavir and Tenofovir

EXPERIMENTAL

Drug: Tenofovir; Drug: Entecavir

Entecavir

ACTIVE COMPARATOR

Drug: Entecavir

Interventions

Tenofovir DRUG

Participants will be given tenofovir 300mg (1 capsule) qd po two weeks before the first cycle of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Tenofovir will be given until the copy count of HBV DNA drops below 1\*10\^3/L.

Entecavir and Tenofovir

Entecavir DRUG

Participants will be given entecavir 0.5 mg (1 capsule) qd po from two weeks before the first cycle of treatment until one year after the end of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Entecavir will be given until one year after the end of treatment.

Entecavir; Entecavir and Tenofovir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Treatment-naive, pathologically confirmed diagnosis of B-cell lymphomas with the viral load of HBV DNA\>1\*10\^3/L
• Age≥18 years old
• Measurable lesions in radiographic images, defined as at least one well-defined lesions/knots, with both the long diameter and the short diameter≥1.5cm
• Life expectancy of at least 3 months according to researchers' judgement
• Written informed consent must be provided by participants or their legal representatives prior to any research examination or procedure

You may not qualify if:

• Creatine\<50mL/min
• Any medical condition that may affect the conduction of this study according to researchers' judgement

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Shanghai Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, B-Cell

Interventions

Tenofovir; entecavir

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: First Deputy Director of Shanghai Institute of Hematology

Study Record Dates

• First Submitted: August 28, 2020
• First Posted: September 4, 2020
• Study Start: July 3, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2024
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

CN (1)