Phase 2
Completed N=132
Safety of PCI-32765 in Chronic Lymphocytic Leukemia
Source: ClinicalTrials.gov NCT01105247 ↗Enrolled (actual)
132
Serious AEs
51.5%
Results posted
Mar 2014
Primary outcomePrimary: Number of Participants With Treatment Emergent Adverse Events (AEs) — 116; 11 Participants
Summary
The purpose of this study is to establish the safety and efficacy of orally administered PCI-32765 in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) |
116; 11 | — |
| SECONDARY Food Effect Cohort Assessments |
1.65 | — |
| SECONDARY Progression Free Survival Rate at 24 Months |
96.3; 73.6; NA | — |
| SECONDARY Percentage of Participants Achieving Response |
71; 75.3; 56.3 | — |
Eligibility Criteria
Inclusion Criteria
- FOR TREATMENT-NAIVE GROUP ONLY: Men and women ≥ 65 years of age with confirmed diagnosis of CLL/SLL, who require treatment per NCI or International Working Group guidelines 15-18
- FOR RELAPSED/REFRACTORY GROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL following previous therapy(ie, failed ≥ 2 previous treatments for CLL/SLL and at least 1 regimen had to have had a purine analog [eg, fludarabine] for subjects with CLL)
- FOR HIGH-RISK RELAPSED/ REFRACTORYGROUP ONLY: Men and women ≥ 18 years of age with a confirmed diagnosis of relapsed/refractory CLL/SLL with suboptimal response to chemoimmunotherapy, defined as progression of disease within 24 months of initiation of a regimen containing at least a nucleoside analogue or bendamustine in combination with a monoclonal antibody or failure to respond to such a regimen. (Note: a minimum of 2 cycles of chemoimmunotherapy required for eligibility)
- ECOG performance status of ≤ 2
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
Exclusion Criteria
- Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for at least 2 years or which will not limit survival to 470 msec
- Lactating or pregnant
Data sourced from ClinicalTrials.gov (NCT01105247). 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. Informational only — not medical advice.