Phase 2
N=144
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
Chronic Lymphocytic Leukemia With 17p Deletion · Small Lymphocytic Lymphoma With 17p Deletion
Bottom Line
View on ClinicalTrials.gov: NCT01744691 ↗Enrolled (actual)
144
Serious AEs
52.8%
Results posted
Jun 2015
Primary outcome: Primary: Overall Response Rate — 77.8 % of participants with response by PI
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibrutinib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pharmacyclics LLC.
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate |
77.8 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
144 | — |
Summary
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
Eligibility Criteria
Key Inclusion Criteria
- Documentation of del (17p13.1)
- Must have relapsed or refractory CLL/SLL after receiving at least 1 prior line of systemic therapy.
- Measurable nodal disease by computed tomography (CT)
Key Exclusion Criteria
- History or current evidence of Richter's transformation or prolymphocytic leukemia
- Prior hematologic stem cell transplantation <6 months from study enrollment or any ongoing GVHD
- Prior exposure to ibrutinib
Data sourced from ClinicalTrials.gov (NCT01744691). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.