Hepatitis B, Lymphoma, Non-Hodgkin
Conditions
Keywords
Non-Hodgkin, Lymphoma, Hepatitis B, Tenofovir, Viread
Brief 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.
Interventions
DRUGTenofovir disoproxil
DRUGPlacebo Oral Tablet
Sponsors
University Health Network, Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of reverse seroconversion | 12 months post-chemotherapy | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Severe HBV-associated hepatitis | 12 months post-chemotherapy |
| HBV-related liver failure | 12 months post-chemotherapy |
| Liver-related death | 12 months post-chemotherapy |
| Rates of HBV Reactivation | 12 months post-chemotherapy |
| Time to start chemotherapy | 12 months post-chemotherapy |
| Chemotherapy interruption | 12 months post-chemotherapy |
| All-cause mortality | 12 months post-chemotherapy |
| Treatment-related adverse effects (AEs) | 12 months post-chemotherapy |
Countries
Canada
Contacts
Primary ContactJordan Feld, MD
Backup ContactJamuna Nanthakumar, CCRP
Outcome results
None listed