Clinical trials: Ibrutinib
Lymphoma, B-Cell, Small Lymphocytic Lymphoma
A Study of Nemtabrutinib (MK-1026) in Participants With Relapsed or Refractory Hematologic Malignancies (ARQ 531-101/MK-1026-001)
This study aims to evaluate the safety, tolerability, pharmacodynamic, and pharmacokinetic (PK) of nemtabrutinib (formerly ARQ 531) tablets in selected participants with relapsed or refractory hematologic malignancies.
- Conditions
- Lymphoma, B-Cell, Small Lymphocytic Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom Macroglobulinemia
- Trial name
- NCT03162536
- Testing
- Nemtabrutinib
- Where
- 10 sites in United States
- Volunteers
- 190 people
- Sponsor
- ArQule, Inc., a subsidiary of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc. (Rahway, NJ USA)
Chronic Lymphocytic Leukemia
Acalabrutinib Safety Study in Untreated and Relapsed or Refractory Chronic Lymphocytic Leukemia Patients
This is a global, Phase IIIb, multicenter, open-label, single-arm study to evaluate the safety and efficacy of acalabrutinib 100 mg twice daily (bid) in approximately 540 participants with chronic lymphocytic leukemia (CLL).
- Trial name
- ASSURE (NCT04008706)
- Testing
- Acalabrutinib
- Where
- 108 sites in United States, Australia and 15 more
- Volunteers
- 552 people
- Sponsor
- AstraZeneca
Relapsed or Refractory Mantle Cell Lymphoma
An Open Label Treatment Use Protocol for Ibrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
The purpose of this study is to provide patients who have relapsed or refractory Mantle Cell Lymphoma (MCL) with early access to an investigational medication called ibrutinib (PCI-32765) and to collect safety information about…
- Trial name
- NCT01833039
- Testing
- Ibrutinib
- Where
- 51 sites in United States, Brazil and 1 more
- Sponsor
- Janssen Biotech, Inc.
B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
- Conditions
- B-cell Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Prolymphocyctic Leukemia, Richter's Transformation
- Trial name
- PCYC-1109-CA (NCT01217749)
- Testing
- PCI-32765, ofatumumab
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Pharmacyclics LLC.
Acute Myeloid Leukemia (AML)
Study of Ibrutinib in Subjects With Acute Myeloid Leukemia
The purpose of this study is to evaluate the efficacy, safety and tolerability of ibrutinib alone or in combination with either cytarabine or azacitidine in the treatment of subjects with Acute Myeloid Leukemia (AML) who have…
- Trial name
- NCT02351037
- Testing
- Ibrutinib, Ibrutinib + LD-AraC, Ibrutinib+Azacitidine
- Where
- 9 sites in United States
- Volunteers
- 36 people
- Sponsor
- Pharmacyclics LLC.
Healthy
A Drug Interaction Study to Assess the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults
The purpose of this study is to evaluate the Effect of Omeprazole on the Pharmacokinetics of Ibrutinib in Healthy Adults.
- Trial name
- NCT02638116
- Testing
- Ibrutinib, Omeprazole
- Where
- Belgium
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Chronic Lymphocytic Leukemia
Study to Assess the Efficacy and Safety of Ublituximab and Umbralisib in Participants With Chronic Lymphocytic Leukemia (CLL) Currently Treated With Ibrutinib, Acalabrutinib or Venetoclax
Phase 2, two cohort trial evaluating the addition of ublituximab and umbralisib on the rate of minimal residual disease (MRD) negativity in participants with Chronic Lymphocytic Leukemia (CLL), who are currently on treatment with…
- Trial name
- NCT04016805
- Testing
- Ublituximab, Umbralisib, Ibrutinib
- Where
- 3 sites in United States
- Volunteers
- 41 people
- Sponsor
- TG Therapeutics, Inc.
Healthy
Study to Assess the Bioequivalence of Ibrutinib 140 Milligram (mg) Tablet to 140 mg IMBRUVICA Capsule
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02877225
- Testing
- Ibrutinib, IMBRUVICA
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC
Non-Hodgkin Lymphoma
A Study to Evaluate Adverse Events and Change in Disease Activity of Subcutaneous (SC) Epcoritamab in Combination With Oral and Intravenous Anti-Neoplastic Agents in Adult Participants With Non-Hodgkin Lymphoma
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cell (a white blood cell responsible for fighting infections).
- Trial name
- NCT05283720
- Testing
- Epcoritamab, Lenalidomide, Ibrutinib
- Where
- 76 sites in United States, China and 11 more
- Volunteers
- 264 people
- Sponsor
- Genmab
Lymphoma, Mantle-Cell
Phase IIa Study of Copanlisib in Relapsed or Refractory Mantle Cell Lymphoma (MCL)
The primary objective of this study is to assess objective response rate (ORR) in patients with relapsed or refractory MCL who failed ibrutinib treatment or were unable to tolerate ibrutinib.
- Trial name
- NCT02455297
- Testing
- Copanlisib (BAY80-6946)
- Where
- 5 sites in United States
- Volunteers
- 4 people
- Sponsor
- Bayer
Recurrent Mature B-cell Neoplasms
A Study to Evaluate the Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Patients With Recurrent Mature B-Cell Neoplasms
The purpose of this study is to evaluate the safety and tolerability of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in Japanese patients with recurrent mature B-cell neoplasms.
- Trial name
- NCT01704963
- Testing
- PCI-32765
- Where
- 4 sites in Japan
- Volunteers
- 15 people
- Sponsor
- Janssen Pharmaceutical K.K.
Multiple Myeloma
Study of BTK Inhibitor, Ibrutinib in Combination With Carfilzomib in Subjects With Relapsed and Refractory Multiple Myeloma
A MULTICENTER PHASE 1/2B STUDY OF THE BRUTON'S TYROSINE KINASE INHIBITOR, IBRUTINIB (PCI-32765), IN COMBINATION WITH CARFILZOMIB (KYPROLIS™) IN SUBJECTS WITH RELAPSED OR RELAPSED AND REFRACTORY MULTIPLE MYELOMA
- Trial name
- NCT01962792
- Testing
- Ibrutinib, Carfilzomib, Dexamethasone
- Where
- 17 sites in United States, Canada
- Volunteers
- 84 people
- Sponsor
- Pharmacyclics LLC.
Chronic Lymphocytic Leukemia With 17p Deletion, Small Lymphocytic Lymphoma With 17p Deletion
A Multicenter Phase 2 Study of Ibrutinib in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL) With 17p Deletion
An Open-label, Single arm, Multicenter Phase 2 Study of the Bruton's Tyrosine Kinase Inhibitor ibrutinib in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma with 17p Deletion
- Trial name
- NCT01744691
- Testing
- Ibrutinib
- Where
- 55 sites in United States, Australia and 7 more
- Volunteers
- 145 people
- Sponsor
- Pharmacyclics LLC.
Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Mantle-Cell
A Study to Assess Safety of ImbruvicaTM in Indian Participants With Chronic Lymphocytic Leukemia or Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy or Chronic Lymphocytic Leukemia With 17p Deletion
The primary purpose of this study is to evaluate the post-marketing safety of ImbruvicaTM (ibrutinib capsule 140 milligram [mg]) under actual conditions of use, and to understand the incidence of adverse events (AEs) (serious and…
- Trial name
- NCT03190330
- Testing
- Ibrutinib 420 mg, Ibrutinib 560 mg
- Where
- 10 sites in India
- Volunteers
- 75 people
- Sponsor
- Johnson & Johnson Private Limited
Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell
A Study to Determine Dose, Safety, and Efficacy of Durvalumab as Monotherapy and in Combination Therapy in Subjects With Lymphoma or Chronic Lymphocytic Leukemia
This study is designed to determine the recommended phase 2 dose (RP2D), and the safety, and efficacy of durvalumab as monotherapy and when given in combination with lenalidomide and rituximab; ibrutinib; or bendamustine and…
- Trial name
- FUSION NHL 001 (NCT02733042)
- Testing
- Durvalumab, Lenalidomide, Rituximab
- Where
- 66 sites in United States, France and 5 more
- Volunteers
- 106 people
- Sponsor
- Celgene
Lymphocytic Leukemia
A Study of Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Treatment-naive Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
The purpose of this study is to evaluate the safety of Ibrutinib in Japanese participants with treatment-naive chronic lymphocytic leukemia ( CLL) or small lymphocytic lymphoma (SLL).
- Trial name
- NCT02556892
- Testing
- Ibrutinib
- Where
- 8 sites in Japan
- Volunteers
- 8 people
- Sponsor
- Janssen Pharmaceutical K.K.
Healthy Volunteers
A Study to Determine the Effect of Food on the Pharmacokinetics of PCI-32765
The purpose of this study is to compare the effect of food and two modified fasting regimens on the pharmacokinetics (study of what the body does to a drug) of PCI-32765 in healthy adult participants.
- Trial name
- NCT01820936
- Testing
- Sequence 1: PCI-32765, Sequence 2: PCI-32765, Sequence 3: PCI-32765
- Where
- United States
- Volunteers
- 52 people
- Sponsor
- Janssen Research & Development, LLC
Leukemia, Lymphocytic, Chronic, B-Cell
A Study of the Combination of Ibrutinib Plus Venetoclax Versus Chlorambucil Plus Obinutuzumab for the First-line Treatment of Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
The purpose of this study is to assess progression-free survival (PFS) from treatment with ibrutinib plus venetoclax (I+VEN) compared with obinutuzumab plus chlorambucil (G-Clb) as assessed by an Independent Review Committee…
- Trial name
- GLOW (NCT03462719)
- Testing
- Ibrutinib, Venetoclax, Chlorambucil
- Where
- 88 sites in United States, Belgium and 12 more
- Volunteers
- 211 people
- Sponsor
- Janssen Research & Development, LLC
Follicular Lymphoma
Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study to evaluate the efficacy and safety of ibrutinib in combination with rituximab versus placebo in combination with rituximab in treatment naïve…
- Trial name
- NCT02947347
- Testing
- Ibrutinib Oral Capsule, Rituximab
- Where
- 128 sites in United States, Australia and 17 more
- Volunteers
- 445 people
- Sponsor
- Pharmacyclics LLC.
Healthy
Study to Assess the Bioequivalence of Ibrutinib 560- Milligram (mg) Tablet to Four 140 -mg IMBRUVICA Capsules
The purpose of this study is to demonstrate the bioequivalence (BE) of a new formulation of ibrutinib to the marketed Imbruvica formulation in healthy adults under fasted conditions.
- Trial name
- NCT02841150
- Testing
- IMBRUVICA (Treatment A), Ibrutinib (Treatment B)
- Where
- United States
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Janssen Research & Development, LLC