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

• Sponsor: Ruijin Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04539119
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 50
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
B-cell Lymphoma; HBV	Drug: Tenofovir; Drug: Entecavir	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Comparative Study of the Efficacy and Safety of Entecavir and Tenofovir Versus Entecavir Alone in the Treatment of Hepatitis B DNA-positive Patients With Lymphomas
• Actual Study Start Date: Jul 3, 2020
• Anticipated Primary Completion Date: Sep 1, 2022
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Entecavir and Tenofovir	Drug: Tenofovir; 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.; Drug: Entecavir; 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.
Active Comparator: Entecavir	Drug: Entecavir; 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.

Outcome Measures

Primary Outcome Measures

1. The rate of successful HBV replication inhibition at cycle 2 [At the start of cycle 2 (each cycle is 21-28 days)]

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

Secondary Outcome Measures

1. Time to successful HBV replication inhibition [During the intervention]

   The time needed to lower the copy count of HBV DNA to 1*10^3/L

2. 2-year PFS [2 years after enrollment]

   Progression free survival

3. 2-year OS [2 years after enrollment]

   Overall survival

4. Complete response rate [After the completion of first-line chemotherapy, an average of 4 months from enrollment]

5. The incidence of adverse events [From enrollment to study completion, an maximum of 3 years.]

Other Outcome Measures

1. Associated factors for successful inhibition of HBV replication [From enrollment to study completion, an maximum of 3 years.]

   Biomarkers measured in tumor tissues and peripheral blood

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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

Exclusion Criteria:

• Creatine<50mL/min

• Any medical condition that may affect the conduction of this study according to researchers' judgement

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Ruijin Hospital	Shanghai	Shanghai	China	200025

Sponsors and Collaborators

• Ruijin Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhao Weili, First Deputy Director of Shanghai Institute of Hematology, Ruijin Hospital
• ClinicalTrials.gov Identifier: NCT04539119
• Other Study ID Numbers: EnTe-HBV
• First Posted: Sep 4, 2020
• Last Update Posted: Sep 4, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lymphoma; Tenofovir; Entecavir

Study Results

No Results Posted as of Sep 4, 2020