Abstract
Ibrutinib is an orally administered, covalent inhibitor of Bruton's tyrosine kinase with activity in B-cell malignancies based on Phase I/II studies. We describe the design and rationale for the Phase III HELIOS trial (trial registration: EudraCT No. 2012-000600-15; UTN No. U1111-1135-3745) investigating whether ibrutinib added to bendamustine and rituximab (BR) provides benefits over BR alone in patients with relapsed/refractory chronic lymphocytic leukemia/small lymphocytic lymphoma. Eligible patients must have relapsed/refractory disease measurable on CT scan and meet ≥1 International Workshop on Chronic Lymphocytic Leukemia criterion for requiring treatment; patients with del(17p) are excluded. All patients receive BR (maximum six cycles) as background therapy and are randomized 1:1 to placebo or ibrutinib 420 mg/day. Treatment with ibrutinib or placebo will start concomitantly with BR and continue until disease progression or unacceptable toxicity. The primary end point is progression-free survival. Secondary end points include safety, objective response rate, overall survival, rate of minimal residual disease-negative remissions, and patient-reported outcomes. Tumor response will be assessed using the International Workshop on Chronic Lymphocytic Leukemia guidelines.
Original language | English (US) |
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Pages (from-to) | 51-59 |
Number of pages | 9 |
Journal | Future Oncology |
Volume | 11 |
Issue number | 1 |
DOIs | |
State | Published - Jan 1 2015 |
Keywords
- B-cell receptor signaling
- Bruton's tyrosine kinase
- bendamustine
- chronic lymphocytic leukemia
- ibrutinib
- rituximab
- small lymphocytic lymphoma
ASJC Scopus subject areas
- Oncology
- Cancer Research