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NCT01722487 - Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Versus Chlorambucil in Patients 65 Years or Older With Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma


CSR Summary

Not Yet Available


Data Specification

Available upon data request approval


Annotated CRF

Available upon data request approval

Product Info

Generic Name
Ibrutinib
Product Name
IMBRUVICA®
Therapeutic Area
Cancers and Other Neoplasms
Enrollment
269
% Female
37.2%
% White
N/A
Product Class
Kinase Inhibitors
Sponsor Protocol Number
PCYC-1115-CA
Data Partner
Johnson & Johnson
Condition Studied
Leukemia, Chronic Lymphocytic
Mean/Median Age (Years)
73.3

Supporting Documentation

Clinical Study Report
Collected Datasets
Data Definition Specification
Annotated Case Report Form
Protocol with Amendments
Statistical Analysis Plan
Study Phase 
3

Disclaimer

Clinical study data provided through this site do not replace the official labeling of a given drug product, which presents benefits and risks of the product for approved use(s). Before prescribing any product, health care professionals should consult the current prescribing information approved in their country. Patients seeking information may consult with their health care professional about the product, for which health authority approved written patient information may be available.