Tenofovir to Prevent HBV Reactivation

Lymphoma Clinical Trial

Official title:

A Multi-centre Phase III Study to Evaluate Pre-emptive Tenofovir for Prevention of Hepatitis B Virus Reactivation in HBsAg Negative/Anti-HBc Positive Individuals Undergoing Anti-CD20-based Chemotherapy for Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02186574
• Other study ID #: JF62014
• Status: Recruiting
• Phase: Phase 3
• Start date: May 2015
• Est. completion date: February 2021

Study information

• Verified date: December 2019
• Source: University Health Network, Toronto
• Contact: Jordan Feld, MD
• Phone: 416-340-4584
• Email: jordan.feld[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine how effective preemptive tenofovir therapy is in preventing the re-activation of Hepatitis B infection, in patients who are receiving rituximab-based chemotherapy for Non-Hodgkin's Lymphoma or CLL/SLL. The rate of re-activation will be compared between patients who receive preemptive tenofovir and patients who receive tenofovir as needed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 184
• Est. completion date: February 2021
• Est. primary completion date: February 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. = 18 years of age

2. Diagnosis of non-Hodgkin's lymphoma to be treated with rituximab-based chemotherapy

3. HBsAg negative, anti-HBc positive

Exclusion Criteria:

1. Current therapy with known activity against HBV

2. Screening ALT > 10 x ULN

3. Screening ALT >2 and <10 xULN with HBV DNA > 2000 IU/mL (indicates active HBV infection despite HBsAg negative and require antiviral therapy)

4. Life expectancy < 3 months

5. HBsAg positive

6. HIV co-infection

7. Active HCV co-infection (HCV RNA positive)

8. Creatinine clearance <50 mL/min

9. Intolerance to tenofovir

10. Women of child-bearing potential unwilling to take contraception during the study period

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Lymphoma
• Non-Hodgkin

Intervention

Drug:
• Tenofovir disoproxil

• Placebo Oral Tablet

Locations

Country	Name	City	State
Canada	Princess Margaret Cancer Centre	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of reverse seroconversion	The difference in the rate of reverse seroconversion or Hepatitis B (HBV)-associated hepatitis (definition: appearance of HBsAg in the serum with or without detectable HBV DNA in a patient who was previously HBsAg-/cAb+.) between the intervention and placebo groups.	12 months post-chemotherapy
Secondary	Rates of HBV Reactivation		12 months post-chemotherapy
Secondary	Severe HBV-associated hepatitis		12 months post-chemotherapy
Secondary	HBV-related liver failure		12 months post-chemotherapy
Secondary	Liver-related death		12 months post-chemotherapy
Secondary	Treatment-related adverse effects (AEs)		12 months post-chemotherapy
Secondary	Time to start chemotherapy		12 months post-chemotherapy
Secondary	Chemotherapy interruption		12 months post-chemotherapy
Secondary	All-cause mortality		12 months post-chemotherapy