Clinical Trial: Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy and Safety of Ibrutinib in Patients With Chronic Lymphocytic Leukemia and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hep
Brief Summary: Efficacy and Safety of ibrutinib in patients with chronic lymphocytic leukemia and other indolent B-cell lymphomas who are chronic hepatitis B virus carriers or occult hepatitis B virus carriers
Detailed Summary:
Ibrutinib is a selective oral Burton tyrosine kinase inhibitor. Through interfering with the downstream pathways of B-cell receptor signaling, it inhibits proliferation and induces apoptosis in many B-cell lymphoid malignancies. The clinical benefit of ibrutinib has been demonstrated in patients with relapsed/refractory chronic lymphocytic leukaemia, mantle cell lymphoma, small lymphocytic lymphoma, and other indolent B-cell non-Hodgkin lymphomas.
The pivotal trials of ibrutinib excluded HBsAg+ patients. Therefore, the effects of ibrutinib on HBsAg+ and anti-HBc+ patients remain entirely undefined. In view of the B-cell signaling inhibitory activity of ibrutinib, which might be more potent than rituximab in suppressing B-cells, HBV reactivation in patients exposed previously to HBV infection, including chronic HBV carriers and occult HBV carriers, could be a major clinical problem.
To enable ibrutinib to be prescribed in Asia and other regions of the world where HBV is endemic, evidence-based recommendations on prevention of HBV reactivation in at-risk populations, including chronic HBV carriers (HBsAg+), and occult HBV carriers (HBsAg- but anti-HBc+), are urgently needed.
The following treatment regimens will be adopted. Relapsed / refractory chronic lymphocytic leukemia and Waldenstrom macroglobulinaemia (lymphoplasmacytic lymphoma): 420 mg daily.
Relapsed / refractory mantle cell lymphoma: 560 mg daily. Relapsed / refractory indolent B-cell non-Hodgkin lymphoma: 560 mg daily. Treatment is continued until disease progression.
A total of 62 patients will be recruited, including 16 HBsAg+ patients, and 46 occult HBV carriers
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Sponsor: The University of Hong Kong
Current Primary Outcome:
- Overall response rate (ORR) [ Time Frame: 2 years ]proportion of patients achieving CR or partial remission (PR)
- Duration of remission [ Time Frame: two year ]
- Rates of HBV Reactivation while on Ibrutinib therapy [ Time Frame: two year ]
- Adverse events and severe adverse events [ Time Frame: two year ]Incidence of AE and SAE by severity grading as assessed according to CTCAE v4.03
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: The University of Hong Kong
Dates:
Date Received: December 2, 2016
Date Started: December 2016
Date Completion: June 2021
Last Updated: December 8, 2016
Last Verified: December 2016