Phase 1
Completed N=33
Safety and Tolerability Study of PCI-32765 Combined With Fludarabine/Cyclophosphamide/Rituximab (FCR) and Bendamustine/Rituximab (BR) in Chronic Lymphocytic Leukemia (CLL)
Source: ClinicalTrials.gov NCT01292135 ↗Enrolled (actual)
33
Serious AEs
21.2%
Results posted
Jul 2014
Primary outcomePrimary: Incidence of Prolonged Hematologic Toxicity Started in Cycle 1 — 0; 0 Percentage of Participants
Summary
The purpose of this study is to establish the safety of orally administered PCI-32765 in combination with fludarabine/cyclophosphamide/rituximab (FCR) and bendamustine/rituximab (BR) in patients with chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma(SLL).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Prolonged Hematologic Toxicity Started in Cycle 1 |
0; 0 | — |
| SECONDARY Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib |
53.3; 33.3 | — |
| SECONDARY Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0 |
66.7; 0 | — |
| SECONDARY Overall Incidence of Serious Adverse Events (SAEs) |
20; 33.3 | — |
| SECONDARY Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR]) |
93.3; 100 | — |
| SECONDARY Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline |
76.2 | — |
| SECONDARY Progression Free Survival Rate at 12 Months |
85.9; 100 | — |
Eligibility Criteria
Inclusion Criteria
- Histologically confirmed CLL or SLL and satisfying at least 1 of the following criteria for requiring treatment:
- Progressive splenomegaly and/or lymphadenopathy identified by physical examination or radiographic studies
- Anemia ( 10% over the preceding 6 months
- NCI CTCAE Grade 2 or 3 fatigue
- Fevers > 100.5° or night sweats for > 2 weeks without evidence of infection
- Progressive lymphocytosis with an increase of > 50% over a 2 month period or an anticipated doubling time of 2.0 x ULN or creatinine clearance < 40 mL/min
Data sourced from ClinicalTrials.gov (NCT01292135). 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.