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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-emptive tenofovir | Active Comparator | Tenofovir disoproxil |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil | Drug |
|
| |
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rates of HBV Reactivation | 12 months post-chemotherapy | |
| Severe HBV-associated hepatitis | 12 months post-chemotherapy | |
| HBV-related liver failure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jordan Feld, MD | Contact | 416-340-4584 | jordan.feld@uhn.ca | |
| Jamuna Nanthakumar, CCRP | Contact | 416-340-4800 | 6453 | jnanthak@uhnresearch.ca |
| Name | Affiliation | Role |
|---|---|---|
| Harry Janssen, MD | University Health Network, Toronto | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Toronto General Hospital | Active, not recruiting | Toronto | Ontario | M5G 2C4 | Canada | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41335575 | Derived | Tabataba Vakili S, Hirode G, Zahoor A, Saunthar A, Feld JB, Hansen BE, Syeda A, Janssen HLA, Kukreti V, Kuruvilla J, Prica A, Cheung M, Buckstein R, Hicks L, Coffin CS, Street LE, Disperati P, Chan KK, Crump M, Feld JJ. Tenofovir alafenamide for prevention of HBV reactivation in HBsAg-negative, anti-HBc-positive patients undergoing rituximab-based chemotherapy: A multicenter randomized controlled trial. Hepatol Commun. 2025 Dec 3;9(12):e0859. doi: 10.1097/HC9.0000000000000859. eCollection 2025 Dec 1. |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
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| Drug |
|
|
| 12 months post-chemotherapy |
| Liver-related death | 12 months post-chemotherapy |
| Treatment-related adverse effects (AEs) | 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 |
| Princess Margaret Cancer Centre |
| Recruiting |
| Toronto |
| Ontario |
| M5G 2M9 |
| Canada |
|
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |