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).
This is a Phase 1b, open-label, parallel-group, nonrandomized, multicenter study of PCI 32765 420 mg once daily oral (PO) administration in combination with 2 different chemotherapy regimens in subjects with relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
33
420 mg daily
Dana Farber Cancer Center
Boston, Massachusetts, United States
CLL Research and Treatment Program
New Hyde Park, New York, United States
Weill Medical College of Cornell University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Incidence of Prolonged Hematologic Toxicity Started in Cycle 1
Time frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Incidence of Adverse Events Requiring Dose Delay or Discontinuation of Ibrutinib
Time frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Incidence of Grade ≥3 Adverse Events (AEs) Per NCI CTCAE V4.0
Time frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Incidence of Serious Adverse Events (SAEs)
Time frame: From First day of dose to 30 days after last dose of any study medication. Participants were followed with a median follow-up time of 15.8 months.
Overall Response Rate (Complete Response [CR] + Complete Response With Incomplete Marrow Recovery [CRi] + Nodular Partial Response [nPR] + Partial Response [PR])
Response criteria are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. response requires 50% reduction in lymph node size. Assessment of response to treatment will be done every 2 cycles for the first 6 months and then every 3 months thereafter until disease progression or prior to the administration of a new anticancer therapy and at follow-up visits.
Time frame: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
Sustained Hematologic Improvement in Subjects With Neutropenia, Anemia, or Thrombocytopenia at Baseline
Time frame: From first response assessment to last response assessment. Participants were followed with a median follow-up time of 15.8 months.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sarah Cannon Research Institute
Nashville, Tennessee, United States
MD Anderson
Houston, Texas, United States
Progression Free Survival Rate at 12 Months
Criteria for progression are as outlined in the IWCLL 2008 criteria (Hallek 2008) and as assessed by investigator, e.g. progression defined as a 50% increase in lymph node size.
Time frame: From first dose of any study medication to 12 months after first dose to progressive disease or death or the last clinical assessment before receiving new anticancer therapy or loss to follow-up, whichever occured the earliest.