Areas of Study

PCYC–1102

The purpose of this Phase 1b/2 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 May 23, 2023)

PCYC–1112, RESONATE

The purpose of this Phase 3 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 May 23, 2023)

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 May 23, 20203

CLL3001, HELIOS

PCYC–1130, iLLUMINATE

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02264574 (Accessed May 23, 2023)

PCYC–1126E/ECOG

CLL3011, GLOW

PCYC–1142, CAPTIVATE

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02910583 (Access May 23, 2023)

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 May 23, 2023)

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 May 23, 2023)

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 May 23, 2023)

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 May 23, 2023)

PCYC–1118e

PCYC–1127, iNNOVATE

The purpose of this Phase 3 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 May 23, 2023)

PCYC–1141, PERSPECTIVE

The purpose of this Phase 3 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 May 23, 2023)

FLR3001, SELENE

The purpose of this Phase 3 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 May 23, 2023)

PCYC–1123

PCYC–1129

The purpose of this Phase 1b/2 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 May 23, 2023)

PCYC–1140, INTEGRATE

Phase 3 study evaluating 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 May 23, 2023)

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 May 23, 2023)

LYM3003, SPARKLE

The purpose of this Phase 3, randomized, open-label study is to evaluate the safety and efficacy 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 May 23, 2023)

PCYC–1128

The purpose of of this Phase 1b/2 study is to evaluate the safety, tolerability, and efficacy of single agent ibrutinib or the combination treatments of ibrutinib with everolimus, paclitaxel, docetaxel, pembrolizumab, or cetuximab in select advanced gastrointestinal and genitourinary tumors.

Clinical Trials.gov. https://clinicaltrials.gov/ct2/show/NCT02599324 (Accessed May 23, 2023)