Areas of Study
We are committed to fully exploring the potential of IMBRUVICA® (ibrutinib)
Ibrutinib: Bruton's tyrosine kinase (BTK) inhibitor
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL) All Lines of Treatment
PCYC–1102
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. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01105247 (Accessed November 3, 2017)
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL) Previously Treated Patients
PCYC–1112, RESONATE
The purpose of the study is to evaluate whether treatment with ibrutinib as a monotherapy results in a clinically significant improvement in progression free survival (PFS) as compared to treatment with ofatumumab in patients with relapsed or refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL). Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01578707 (Accessed November 3, 2017)
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL) First Line Treatment Elderly and/or Unfit Patients
PCYC–1115 RESONATE-2, PCYC-1116
A Randomized, Multicenter, Open-label, Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor PCI-32765 versus Chlorambucil in Patients 65 Years or Older with Treatment-naive Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01724346 (Accessed November 3, 2017)
CLL3001, HELIOS
PCYC–1130, iLLUMINATE
An open-label, multi-center randomized, phase 3 study of ibrutinib combined with obinutuzumab versus chlorambucil in combination with obinutuzumab in subjects with treatment-naïve Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02264574 (Accessed November 3, 2017)
Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma (CLL/SLL) First Line Treatment Young/Fit Patients
PCYC–1126E/ECOG
CLL3011, GLOW
A Randomized, Open-label, Phase 3 Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Subjects With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL). Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/record/NCT03462719 (Accessed July, 2018)
PCYC–1142, CAPTIVATE
This study is to determine the clinical minimum residual disease (MRD) response with the combination of ibrutinib plus venetoclax in subjects with treatment-naive chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02910583 (Access November 3, 2017)
Mantle Cell Lymphoma (MCL) Previously Treated Patients
PCYC–1104
The primary objective of this study was to evaluate the efficacy of ibrutinib in participants with relapsed or refractory MCL. The secondary objective was to evaluate the safety of a fixed daily dosing regimen (560 mg daily) of PCI-32765 in this population. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01236391 (Accessed November 3, 2017)
Mantle Cell Lymphoma (MCL) First Line Treatment
MCL3002, SHINE
The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01776840 (Accessed November 3, 2017)
PCYC–1143, SYMPATICO
This Phase 3 multinational, randomized, double-blind study is designed to compare the efficacy and safety of the combination of ibrutinib and venetoclax vs. ibrutinib and placebo in subjects with MCL. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT03112174 (Accessed November 3, 2017)
Waldenström's Macroglobulinemia (WM) Previously Treated Patients
PCYC–1118e
In this research study, the investigators are testing the safety and efficacy of PCI-32765 as a treatment option for relapsed or refractory Waldenstrom's Macroglobulinemia. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01614821 (Accessed November 3, 2017)
Waldenström's Macroglobulinemia (WM) All Lines of Treatment
PCYC–1127, iNNOVATE
The purpose of this study is to evaluate the safety and efficacy of Ibrutinib in combination with Rituximab in subjects with Waldenström's Macroglobulinemia. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02165397 (Accessed November 3, 2017)
Marginal Zone Lymphoma (MZL) Previously Treated Patients
PCYC–1121
Phase 2, open-label, non-randomized, monotherapy study to evaluate the safety and efficacy of ibrutinib in subjects with relapsed/refractory Marginal Zone Lymphoma (MZL). Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01980628 (Accessed November 3, 2017)
Follicular Lymphoma (FL) First Line Treatment Elderly and/or Unfit Patients
PCYC–1141, PERSPECTIVE
The purpose of this study is to evaluate whether the addition of ibrutinib will result in prolongation of progression-free survival (PFS) when compared with rituximab alone in treatment naïve subjects with follicular lymphoma. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02947347 (Accessed November 3, 2017)
Follicular Lymphoma (FL) Previously Treated Patients
FLR3001, SELENE
The purpose of this study is to evaluate the efficacy and safety of ibrutinib administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult participants with previously treated indolent Non-Hodgkin lymphoma. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT01974440 (Accessed November 3, 2017)
Diffuse Large B-Cell Lymphoma (DLBCL) Previously Treated Patients
PCYC–1123
Chronic Graft-versus-Host Disease (cGVHD)
Previously Treated Patients
PCYC–1129
The purpose of this study is to assess the safety and clinical efficacy of ibrutinib in subjects with steroid dependent or refractory Chronic Graft-versus-Host Disease. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02195869 (Accessed November 3, 2017)
Chronic Graft-versus-Host Disease First Line Treatment
PCYC–1140, INTEGRATE
To evaluate the safety and efficacy of ibrutinib in combination with prednisone in subjects with newly diagnosed moderate to severe Chronic Graft-versus-Host Disease. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02959944 (Accessed November 3, 2017)
Previously Treated Pediatrics
PCYC–1146
The purpose of this study is to assess the dosing, safety and clinical efficacy of ibrutinib in pediatric subjects with Chronic Graft-versus-Host Disease. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT03790332 (Accessed March 25, 2019)
Mature B-Cell Non-Hodgkin Lymphomas Previously Treated Pediatrics
LYM3003, SPARKLE
LYM3003, SPARKLE, is a randomized, open-label, safety and efficacy study of ibrutinib in pediatric and young adult patients with relapsed or refractory mature B-cell non-Hodgkin lymphoma and is set up to be conducted in two parts. In Part 1, the purpose is to evaluate the consistency of pharmacokinetics of ibrutinib in pediatric participants versus/as compared to adults. In Part 2, the purpose is to assess efficacy (event-free survival [EFS]) of ibrutinib in combination with rituximab, ifosfamide, carboplatin and etoposide (RICE) or rituximab, vincristine, ifosfamide, carboplatin and idarubicin (RVICI) background therapy compared to RICE or RVICI background therapy alone.
Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02703272 (Accessed September, 2018)
Solid Tumor Previously Treated Patients
PCYC–1128
The purpose of this study is to evaluate the safety, tolerability, and efficacy of the combination treatment of ibrutinib with everolimus, paclitaxel, docetaxel, or cetuximab in selected advanced gastrointestinal and genitourinary tumors. Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02599324 (Accessed November 3, 2017)