- CSR Summary Not Yet Available
- NCT01105247
- Primary Citation
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Trial Information
Generic NameIbrutinibProduct NameIMBRUVICA®Therapeutic AreaCancers and Other NeoplasmsEnrollment133% Female25.8%% WhiteN/A
Product ClassKinase InhibitorsSponsor Protocol NumberPCYC-1102-CAData PartnerJohnson & JohnsonCondition StudiedLeukemia, Chronic Lymphocytic, Lymphoma, Mantle Cell/Small LymphocyticMean/Median Age (Years)66
Supporting Documentation
- Collected Datasets Available
- Protocol with Amendments Available
- Statistical Analysis Plan Available
- Clinical Study Report Available
Approved Data Requests Associated with this Trial
- 2023-5247 : Identifying Prognostic and Predictive Factors for Causal Exposure-Response Analysis of Ibrutinib in treatment of non-Hodgkin Lymphoma
- 2022-5123 : CYP3A4 Interactions and Adverse Drug Reactions in Ibrutinib Therapy: Revisting multiple clinical trials
- 2022-5066 : Predictors of exposure, therapeutic and adverse effects of ibrutinib used in the treatment of B-cell lymphomas
- 2022-4985 : A pooled analysis of clinical trials evaluating BTK inhibitors in CLL to determine if race is a prognostic variable of survival.
- 2020-4386 : Pharmacometric models on lymphocyte dynamics, lymph node size and blood pressure linked to survival in CLL patients treated with ibrutinib
- 2019-3840 : Identifying clinical and electrocardiogram (ECG) findings predicting for tachyarrhythmia in patients on ibrutinib treatment