Imbruvica (ibrutinib) / Royalty, Generic mfg., AbbVie, J&J  >>  Phase 3
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55 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Imbruvica (ibrutinib) / AbbVie, J&J
RESONATE, NCT01578707 / 2012-000694-23: A Phase 3 Study of Ibrutinib (PCI-32765) Versus Ofatumumab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia

Checkmark Approved for 1L CLL in combination with obinutuzumab
Nov 2019 - Nov 2019: Approved for 1L CLL in combination with obinutuzumab
Checkmark Submitted for frontline CLL in combination with obinutuzumab
Nov 2018 - Nov 2018: Submitted for frontline CLL in combination with obinutuzumab
Checkmark EHA 2016
More
Completed
3
391
Europe, US, RoW
ofatumumab, ibrutinib
Pharmacyclics LLC., Janssen Research & Development, LLC
Relapsed or Refractory Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
11/13
10/18
2013-001944-76: A phase III trial to assess ibrutinib plus rituximab against FCR in previously untreated patients with Chronic Lymphocytic Leukaemia (CLL)

 
3
754
Europe
Fludarabine (oral), Fludarabine (IV), Cyclophospamide (oral), Cyclophosphamide (IV), Rituximab, Ibrutinib, Film-coated tablet, , Tablet, Powder for solution for injection, Concentrate for solution for infusion, Capsule, hard, Fludara
University of Leeds, Cancer Research UK/Clinical Trials Advisory and Awards Committee (CRUK/CTAAC), Janssen Pharmaceutica
Chronic Lymphocytic Leukaemia (CLL)., Chronic Lymphocytic Leukaemia (CLL)., Diseases [C] - Blood and lymphatic diseases [C15]
 
 
RESONATE-2, NCT01722487 / 2012-003967-23: Open-label Phase 3 BTK Inhibitor Ibrutinib vs Chlorambucil Patients 65 Years or Older With Treatment-naive CLL or SLL

Checkmark From RESONATE-2 trial in combination with Gazyva for front-line CLL/SLL
Dec 2020 - Dec 2020: From RESONATE-2 trial in combination with Gazyva for front-line CLL/SLL
Checkmark Approved for 1L CLL in combination with obinutuzumab
Nov 2019 - Nov 2019: Approved for 1L CLL in combination with obinutuzumab
Checkmark Submitted for frontline CLL in combination with obinutuzumab
More
Completed
3
269
US, Canada, Europe, RoW
Ibrutinib, Chlorambucil
Pharmacyclics LLC., Janssen Research & Development, LLC
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
05/15
05/15
RAY , NCT01646021 / 2012-000601-74: Study of Ibrutinib (a Bruton's Tyrosine Kinase Inhibitor), Versus Temsirolimus in Patients With Relapsed or Refractory Mantle Cell Lymphoma Who Have Received at Least One Prior Therapy

Checkmark Final 3-year follow-up results from the RAY P3 trial
May 2018 - May 2018: Final 3-year follow-up results from the RAY P3 trial
Checkmark ASCO 2016
May 2016 - May 2016: ASCO 2016
Checkmark Vs. temsirolimus in patients with relapsed or refractory mantle-cell lymphoma
More
Completed
3
280
Canada, Europe, RoW
Ibrutinib, Temsirolimus
Janssen Research & Development, LLC, Pharmacyclics LLC.
Mantle Cell Lymphoma
06/15
12/16
NCT01973387: A Study of PCI-32765 (Ibrutinib) Versus Rituximab in Relapsed or Refractory Chronic Leukemia/Lymphoma

Completed
3
160
RoW
Rituximab, Ibrutinib
Janssen Research & Development, LLC, Pharmacyclics LLC.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
12/15
08/17
2014-001363-12: autologous Transplantation after a Rituximab/Ibrutinib/Ara-c containing iNduction in Generalized mantle cell Lymphoma – a randomized European MCL Network trial

Ongoing
3
870
Europe, RoW
Ibrutinib, PCI-32765, Capsule, hard, Imbruvica
Klinikum der Universität München, Medizinische Klinik und Poliklinik III, HOVON Foundation, KLINIKUM DER UNIVERSITAET MUENCHEN, KroHem, Janssen Pharmaceutica NV, Skåne University Hospital, Department of Oncology, Dutch Cancer Society
Generalized mantle cell Lymphoma, Generalized mantle cell Lymphoma, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
NCT02757040: Combination of Ibrutinib and As2O3 in the Treatment of CLL

Unknown status
3
70
NA
Ibrutinib combined with As2O3, Ibrutinib combined with arsenic trioxide, ibrutinib, BTK inhibitor
Peking University People's Hospital, Beijing Hospital
Leukemia, Lymphocytic, Chronic, B-Cell
12/17
12/18
PHOENIX, NCT01855750 / 2013-000959-40: A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Checkmark Data from PHOENIX trial for frontline DLBCL
Jul 2018 - Jul 2018: Data from PHOENIX trial for frontline DLBCL
Completed
3
838
Europe, Canada, Japan, US, RoW
Ibrutinib, Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone (or equivalent)
Janssen Research & Development, LLC, Pharmacyclics LLC.
Lymphoma
02/18
04/19
iLLUMINATE , NCT02264574 / 2014-002069-31: A Multi-Center Study of Ibrutinib in Combination With Obinutuzumab Versus Chlorambucil in Combination With Obinutuzumab in Patients With Treatment naïve Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

Checkmark From iLLUMINATE trial in combination with Gazyva for 1L CLL/SLL
Dec 2020 - Dec 2020: From iLLUMINATE trial in combination with Gazyva for 1L CLL/SLL
Checkmark Approved for 1L CLL in combination with obinutuzumab
Aug 2019 - Aug 2019: Approved for 1L CLL in combination with obinutuzumab
Checkmark Approved the use of ibrutinib combo obinutuzumab for adult patients with previously untreated CLL/SLL
More
Completed
3
229
Europe, Canada, US, RoW
Ibrutinib, Obinutuzumab, Chlorambucil
Pharmacyclics LLC.
Chronic Lymphocytic Leukemia, Small-Cell Lymphoma
03/18
09/19
ALLIANCE A041202, NCT01886872: Rituximab and Bendamustine Hydrochloride, Rituximab and Ibrutinib, or Ibrutinib Alone in Treating Older Patients With Previously Untreated Chronic Lymphocytic Leukemia

Checkmark Ibrutinib + Rituxan for 1L CLL
Dec 2018 - Dec 2018: Ibrutinib + Rituxan for 1L CLL
Active, not recruiting
3
547
Canada, US
Bendamustine Hydrochloride, Belrapzo, Bendamustin Hydrochloride, Bendeka, CEP 18083, CEP-18083, CEP18083, Cytostasan Hydrochloride, Levact, Ribomustin, SyB L-0501, Treakisym, Treanda, VIVIMUSTA, Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Aspiration, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography, Ibrutinib, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765, Laboratory Biomarker Analysis, Quality-of-Life Assessment, Quality of Life Assessment, Rituximab, ABP 798, ABP-798, ABP798, BI 695500, BI-695500, BI695500, Blitzima, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT P10, CT-P10, CTP10, GP 2013, GP-2013, GP2013, IDEC 102, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, IDEC102, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF 05280586, PF-05280586, PF05280586, Riabni, Ritemvia, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar GP2013, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, Rituximab-abbs, Rituximab-arrx, Rituximab-blit, Rituximab-pvvr, Rituximab-rite, Rituximab-rixa, Rituximab-rixi, Rixathon, Riximyo, RTXM 83, RTXM-83, RTXM83, Ruxience, Truxima
National Cancer Institute (NCI)
Stage I Chronic Lymphocytic Leukemia, Stage II Chronic Lymphocytic Leukemia, Stage III Chronic Lymphocytic Leukemia, Stage IV Chronic Lymphocytic Leukemia
08/18
06/26
RESOLVE, NCT02436668 / 2015-000905-38: Study of Ibrutinib vs Placebo, in Combination With Nab-paclitaxel and Gemcitabine, in the First Line Treatment of Patients With Metastatic Pancreatic Adenocarcinoma

Checkmark RESOLVE trial in 1L pancreatic cancer
Jan 2019 - Jan 2019: RESOLVE trial in 1L pancreatic cancer
Completed
3
430
Europe, US, RoW
Ibrutinib, IMBRUVICA®, Gemcitabine, Nab-paclitaxel
Pharmacyclics LLC.
Metastatic Pancreatic Adenocarcinoma
10/18
04/19
ECOG-ACRIN E1912, NCT02048813: Ibrutinib and Rituximab Compared With Fludarabine Phosphate, Cyclophosphamide, and Rituximab in Treating Patients With Untreated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Checkmark Approved in combination with rituximab for CLL
Jan 2021 - Jan 2021: Approved in combination with rituximab for CLL
Checkmark CHMP Positive opinion in combination with rituximab or obinutuzumab for previously untreated CLL
Oct 2020 - Oct 2020: CHMP Positive opinion in combination with rituximab or obinutuzumab for previously untreated CLL
Checkmark Positive CHMP opinion in combination with rituximab for the treatment of 1L CLL
More
Active, not recruiting
3
529
US
Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719, Fludarabine Phosphate, 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara, SH T 586, Ibrutinib, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765, Laboratory Biomarker Analysis, Pharmacogenomic Study, PHARMACOGENOMIC, Quality-of-Life Assessment, Quality of Life Assessment, Rituximab, ABP 798, ABP-798, ABP798, BI 695500, BI-695500, BI695500, Blitzima, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT P10, CT-P10, CTP10, GP 2013, GP-2013, GP2013, IDEC 102, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, IDEC102, Ikgdar, Mabtas, MabThera, Monoclonal Antibody IDEC-C2B8, PF 05280586, PF-05280586, PF05280586, Riabni, Ritemvia, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, Rituximab Biosimilar GP2013, Rituximab Biosimilar IBI301, Rituximab Biosimilar JHL1101, Rituximab Biosimilar PF-05280586, Rituximab Biosimilar RTXM83, Rituximab Biosimilar SAIT101, Rituximab Biosimilar SIBP-02, rituximab biosimilar TQB2303, Rituximab PVVR, Rituximab-abbs, Rituximab-arrx, Rituximab-blit, Rituximab-pvvr, Rituximab-rite, Rituximab-rixa, Rituximab-rixi, Rixathon, Riximyo, RTXM 83, RTXM-83, RTXM83, Ruxience, Truxima
National Cancer Institute (NCI)
Anemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
10/18
10/26
HELIOS, NCT01611090 / 2012-000600-15: A Study of Ibrutinib in Combination With Bendamustine and Rituximab in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Checkmark HELIOS trial of Imbruvica in combination with bendamustine and rituximab for CLL/SLL
Jun 2016 - Jun 2016: HELIOS trial of Imbruvica in combination with bendamustine and rituximab for CLL/SLL
Checkmark ASCO 2016
May 2016 - May 2016: ASCO 2016
Checkmark In combination with bendamustine and rituximab compared with placebo, bendamustine, and rituximab
More
Completed
3
578
Europe, Canada, US, RoW
Ibrutinib, Bendamustine hydrochloride, Rituximab, Placebo
Janssen Research & Development, LLC, Pharmacyclics LLC.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
01/19
01/19
CLL12, NCT02863718 / 2013-003211-22: Ibrutinib in Previously Untreated Binet Stage a Chronic Lymphocytic Leukemia with Risk of Disease Progression

Completed
3
515
Europe
Ibrutinib, Imbruvica, Placebo
German CLL Study Group, Janssen-Cilag Ltd.
Chronic Lymphocytic Leukemia
03/19
07/22
NCT02414022: Economic Analysis of Alliance A041202 CLL Study

Checkmark Presentation of data from Alliance A041202 CLL study for CLL at ASH 2018
Dec 2018 - Dec 2018: Presentation of data from Alliance A041202 CLL study for CLL at ASH 2018
Active, not recruiting
3
55
Canada
Canadian Cancer Trials Group
Chronic Lymphocytic Leukemia
04/19
04/26
iNNOVATE, NCT02165397 / 2013-005478-22: Ibrutinib With Rituximab in Adults With Waldenström's Macroglobulinemia

Checkmark Submitted for Imbruvica+Rituxan for Waldenström’s macroglobulinemia
Jun 2020 - Jun 2020: Submitted for Imbruvica+Rituxan for Waldenström’s macroglobulinemia
Checkmark Approved in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinemia
Aug 2019 - Aug 2019: Approved in combination with rituximab for the treatment of adult patients with Waldenström's macroglobulinemia
Checkmark Submitted for treatment-naïve Waldenstorm's macroglobulinemia in combination with rituximab
More
Completed
3
181
Europe, Canada, US, RoW
Ibrutinib, PCI-32765, Placebo, Rituximab, Rituxan
Pharmacyclics LLC., Janssen Research & Development, LLC
Waldenström's Macroglobulinemia
11/19
11/19
iNTEGRATE, NCT02959944 / 2016-003286-26: Ibrutinib in Combination With Corticosteroids vs Placebo in Combination With Corticosteroids in Participants With New Onset Chronic Graft Versus Host Disease (cGVHD)

Checkmark From iNTEGRATE trial for 1L cGVHD
Jan 2023 - Jan 2023: From iNTEGRATE trial for 1L cGVHD
Completed
3
193
Europe, Canada, Japan, US, RoW
ibrutinib, IMBRUVICA®, PCI-32765, Placebo, Prednisone
Pharmacyclics LLC., Janssen Research & Development, LLC
Chronic Graft Versus Host Disease
03/20
07/21
GENUINE, NCT02301156: Ublituximab in Combination With Ibrutinib Versus Ibrutinib Alone in Participants With Previously Treated High-Risk Chronic Lymphocytic Leukemia (CLL)

Checkmark From GENUINE trial in combination with ibrutinib in relapsed/refractory high-risk CLL
Feb 2021 - Feb 2021: From GENUINE trial in combination with ibrutinib in relapsed/refractory high-risk CLL
Checkmark From GENUINE trial in combination with ublituximab for high-risk CLL at ASCO 2020
May 2020 - May 2020: From GENUINE trial in combination with ublituximab for high-risk CLL at ASCO 2020
Checkmark From GENUINE trial in combination with ibrutinib in relapsed/refractory CLL with high-risk cytogenetics at ASCO 2020
More
Completed
3
126
US, RoW
Ublituximab, TG-1101, Ibrutinib, IMBRUVICA
TG Therapeutics, Inc.
Chronic Lymphocytic Leukemia
04/20
04/20
REACH3, NCT03112603 / 2016-004432-38: A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation

Checkmark Approved in Korea for acute or chronic GvHD patients aged 12 years and older
May 2022 - May 2022: Approved in Korea for acute or chronic GvHD patients aged 12 years and older
Checkmark CHMP issued a positive opinion for acute or chronic GvHD patients aged 12 years and older
Mar 2022 - Mar 2022: CHMP issued a positive opinion for acute or chronic GvHD patients aged 12 years and older
Checkmark Approved in US for SR-cGVHD
More
Completed
3
330
Europe, Canada, Japan, US, RoW
Ruxolitinib, Jakafi, INCB018424, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX), Mycophenolate mofetil (MMF), mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus), Infliximab, Rituximab, Pentostatin, Imatinib, Ibrutinib
Incyte Corporation
Graft-versus-host Disease (GVHD)
05/20
12/22
NCT02735876: A Study of Acalabrutinib in Combination With Rituximab Versus Ibrutinib Versus Acalabrutinib in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

Withdrawn
3
0
US
acalabrutinib, ibrutinib, rituximab
Acerta Pharma BV
Mantle Cell Lymphoma
06/20
 
ELEVATE-RR, NCT02477696 / 2014-005530-64: Study of Acalabrutinib (ACP-196) Versus Ibrutinib in Previously Treated Participants With High Risk Chronic Lymphocytic Leukemia (CLL)

Checkmark Presentation of data from ELEVATE-RR trial in r/r CLL at ASH 2022
Nov 2022 - Nov 2022: Presentation of data from ELEVATE-RR trial in r/r CLL at ASH 2022
Checkmark From ELEVATE-RR trial in r/r CLL at ASH 2021
Dec 2021 - Dec 2021: From ELEVATE-RR trial in r/r CLL at ASH 2021
Checkmark From ELEVATE-RR trial in combination with Ibrutinib for previously Treated Patients With CLL
More
Active, not recruiting
3
533
Europe, US, RoW
Acalabrutinib, ACP-196, Ibrutinib
Acerta Pharma BV
Chronic Lymphocytic Leukemia
09/20
01/28
NCT02991638: Efficacy and Safety of Ibrutinib in Patients With CLL and Other Indolent B-cell Lymphomas Who Are Chronic Hepatitis B Virus Carriers or Occult Hepatitis B Virus Carriers

Unknown status
3
62
RoW
Ibrutinib, Imbruvica
The University of Hong Kong, Janssen, LP
Chronic Lymphocytic Leukemia, Indolent B-cell Lymphomas, Chronic Hepatitis B, Lymphoma, Small Lymphocytic, Mantle-Cell Lymphoma, Waldenstrom's Macroglobulinaemia, Follicular Lymphoma
12/20
06/21
GLOW, NCT03462719 / 2017-004699-77: 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)

Checkmark New data from the P3 GLOW study in combination with ibrutinib in 1L CLL/SLL at ASH 2022
Dec 2022 - Dec 2022: New data from the P3 GLOW study in combination with ibrutinib in 1L CLL/SLL at ASH 2022
Checkmark Data from GLOW trial in combination with Venclexta for CLL at ASH 2022
Dec 2022 - Dec 2022: Data from GLOW trial in combination with Venclexta for CLL at ASH 2022
Checkmark CHMP positive opinion in a fixed-duration combination regimen venetoclax for adult patients with 1L CLL
More
Active, not recruiting
3
211
Europe, Canada, US, RoW
Ibrutinib, Venetoclax, Chlorambucil, Obinutuzumab, Ibrutinib (as Subsequent Therapy)
Janssen Research & Development, LLC, Pharmacyclics LLC.
Leukemia, Lymphocytic, Chronic, B-Cell
02/21
04/29
TRIANGLE, NCT02858258: ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma

Hourglass May 2019 - Dec 2023 : Regulatory submission in EU for front line maintenance MCL
Recruiting
3
870
Europe
R-CHOP/R-DHAP, rituximab, CHOP, DHAP, Ibrutinib (Induction), Imbruvica, ASCT conditioning, THAM or BEAM, Ibrutinib (Maintenance)
Prof. Dr. M. Dreyling (co-chairman), LMU Klinikum
Mantle Cell Lymphoma
05/21
05/26
NCT02703272 / 2016-000259-28: A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma

Terminated
3
72
Europe, Canada, US, RoW
Ibrutinib, Rituximab, Ifosfamide, Carboplatin, Etoposide, Vincristine, Idarubicin, Dexamethasone
Janssen Research & Development, LLC, Pharmacyclics LLC.
Lymphoma, Non-Hodgkin
06/21
06/21
SHINE , NCT01776840 / 2012-004056-11: A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

Checkmark J&J withdrawn marketing authorization application for Imbruvica in combination with bendamustine and rituximab for 1L MCL based on SHINE study
Dec 2022 - Dec 2022: J&J withdrawn marketing authorization application for Imbruvica in combination with bendamustine and rituximab for 1L MCL based on SHINE study
Checkmark Data from SHINE trial in 1L MCL at ASCO 2022
Jun 2022 - Jun 2022: Data from SHINE trial in 1L MCL at ASCO 2022
Checkmark From SHINE trial in 1L MCL
More
Completed
3
523
Europe, Canada, Japan, US, RoW
Bendamustine, Rituximab, Ibrutinib, Placebo
Janssen Research & Development, LLC, Pharmacyclics LLC.
Mantle Cell Lymphoma
06/21
06/24
2020-004553-72: A clinical study to assess the effectiveness and safety of LOXO-305 compared to standard of care treatment chosen by the Investigator in patients with previously treated Mantle Cell Lymphoma

Not yet recruiting
3
500
Europe, RoW
pirtobrutinib, Ibrutinib, [na], [LOXO-305], Film-coated tablet, Tablet, IMBRUVICA
Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company, LOXO ONCOLOGY INCORPORATED, Loxo Oncology, Inc., a wholly owned subsidiary of Eli Lilly and Company, Loxo Oncology Inc
Mantle cell lymphoma, a cancer of white blood cells (developing in a certain part of the lymph node), which help the body fight infections, Diseases [C] - Cancer [C04]
 
 
NCT03474679: A Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor Ibrutinib in Participants With Steroid Dependent/Refractory Chronic Graft Versus Host Disease (cGVHD)

Completed
3
19
Japan
Ibrutinib, PCI-32765, JNJ-54179060
Janssen Pharmaceutical K.K.
Graft vs Host Disease
11/21
11/21
SELENE , NCT01974440 / 2013-003093-27: A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma

Hourglass Jul 2022 - Dec 2022 : Data from SELENE trial for follicular lymphoma/MZL
Completed
3
403
Europe, Japan, US, RoW
Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, PCI-32765 (Ibrutinib), Placebo
Janssen Research & Development, LLC, Pharmacyclics LLC.
Lymphoma
05/22
06/23
ASPEN, NCT03053440 / 2016-002980-33: A Study Comparing BGB-3111 and Ibrutinib in Participants With Waldenström's Macroglobulinemia (WM)

Hourglass Dec 2023 - Dec 2023 : Data from ASPEN trial for Waldenstrom macroglobulinemia at ASH 2023
Checkmark Approved for the treatment of patients with CLL or SLL based on data from ALPINE and SEQUOIA trials
Jan 2023 - Jan 2023: Approved for the treatment of patients with CLL or SLL based on data from ALPINE and SEQUOIA trials
Checkmark Swissmedic approved for the treatment of 2L Waldenström’s macroglobulinemia
Feb 2022 - Feb 2022: Swissmedic approved for the treatment of 2L Waldenström’s macroglobulinemia
More
Completed
3
201
Europe, US, RoW
BGB-3111, Zanubrutinib, Brukinsa, Ibrutinib, IMBRUVICA
BeiGene
Waldenström's Macroglobulinemia
06/22
06/22
2021-003206-41: A Phase 3 Study Comparing Pirtobrutinib to Ibrutinib in CLL/SLL

Ongoing
3
650
Europe
Pirtobrutinib, Ibrutinib, LOXO-305, Tablet, Capsule, hard, IMBRUVICA
Loxo Oncology, Inc., Loxo Oncology, Inc.
Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma krónikus limfocitás leukémia / kis limfocitás limfóma, Chronic lymphocytic leukaemia/Small Lymphocytic Lymphoma is a type of cancer that affects the white blood cells and tends to progress slowly over many years, Diseases [C] - Cancer [C04]
 
 
ALPINE, NCT03734016 / 2018-001366-42: A Study of Zanubrutinib (BGB-3111) Versus Ibrutinib in Participants With Relapsed/Refractory Chronic Lymphocytic Leukemia

Checkmark Approved for the treatment of patients with CLL or SLL based on data from ALPINE and SEQUOIA trials
Jan 2023 - Jan 2023: Approved for the treatment of patients with CLL or SLL based on data from ALPINE and SEQUOIA trials
Checkmark Data from ALPINE trial for CLL at ASH 2022
Dec 2022 - Dec 2022: Data from ALPINE trial for CLL at ASH 2022
Checkmark FDA approval
More
Completed
3
652
Europe, US, RoW
Zanubrutinib, BGB-3111, Brukinsa, Ibrutinib, Imbruvica
BeiGene
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
08/22
02/24
2022-001547-25: A Phase 3 study of Zilovertamab in addition to Ibrutinib in Subjects with Relapsed or Refractory Mantle Cell Lymphoma Estudio en fase III de zilovertamab en combinación con ibrutinib en pacientes con linfoma de células del manto recidivante o resistente

Ongoing
3
365
Europe
Zilovertamab, Ibrutinib, Zilovertamab, PCI-32765, Solution for infusion, Capsule, hard
Oncternal Therapeutics, Inc, Oncternal Therapeutics, Inc
Relapsed or Refractory Mantle Cell Lymphoma Linfoma de células del manto recidivante o resistente, Mantle Cell Lymphoma Linfoma de células del manto, Diseases [C] - Cancer [C04]
 
 
NCT01724346 / 2012-003968-44: Open-label Extension Study in Patients 65 Years or Older With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Completed
3
269
Europe, Canada, US, RoW
Ibrutinib, PCI-32765, Next-line ibrutinib
Pharmacyclics LLC., Janssen Research & Development, LLC
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
08/23
08/23
BELLWAVE-011, NCT06136559: A Study of Nemtabrutinib (MK-1026) Versus Comparator (Investigator's Choice of Ibrutinib or Acalabrutinib) in First Line (1L) Chronic Lymphocytic Leukemia (CLL)/ Small Lymphocytic Lymphoma (SLL) (MK-1026-011/)

Recruiting
3
1200
Europe, Canada, Japan, US, RoW
Nemtabrutinib, MK-1026, ARQ 531, Ibrutinib, Acalabrutinib
Merck Sharp & Dohme LLC
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
09/32
09/32
GAIA, NCT02950051 / 2015-004936-36: Standard Chemoimmunotherapy (FCR/BR) Versus Rituximab + Venetoclax (RVe) Versus Obinutuzumab (GA101) + Venetoclax (GVe) Versus Obinutuzumab + Ibrutinib + Venetoclax (GIVe) in Fit Patients with Previously Untreated Chronic Lymphocytic Leukemia (CLL) Without Del(17p) or TP53 Mutation

Hourglass Jan 2021 - Dec 2021 : From CLL13 trial in combination with Venclexta for 1L CLL
Completed
3
926
Europe, RoW
Fludarabine, Fludura, Cyclophosphamide, Endoxan, Rituximab, MabThera, Rituxan, Bendamustine, Ribomustin, Levact, Venetoclax, Venclexta, Venclyxto, Obinutuzumab, Gazyva, Gazyvaro, Ibrutinib, Imbruvica
German CLL Study Group, Janssen-Cilag Ltd., Hoffmann-La Roche, AbbVie, Stichting Hemato-Oncologie voor Volwassenen Nederland, Nordic CLL Study Group (NCLLSG), Swiss Group for Clinical Cancer Research, Cancer Trials Ireland, Israeli CLL Study Group
Chronic Lymphocytic Leukemia
02/24
02/24
NCT02443077: Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma

Active, not recruiting
3
94
US, RoW
Autologous Bone Marrow Transplantation, ABMT, Autologous Blood and Marrow Transplantation, Autologous Bone Marrow Transplant, Autologous Marrow Transplantation, Autologous Hematopoietic Stem Cell Transplantation, AHSCT, Autologous, Autologous Hematopoietic Cell Transplantation, Autologous Stem Cell Transplant, Autologous Stem Cell Transplantation, Stem Cell Transplantation, Autologous, Carmustine, BCNU, Becenum, Becenun, BiCNU, Bis(chloroethyl) Nitrosourea, Bis-Chloronitrosourea, Carmubris, Carmustin, Carmustinum, FDA 0345, N,N'-Bis(2-chloroethyl)-N-nitrosourea, Nitrourean, Nitrumon, NSC 409962, NSC409962, SK 27702, SRI 1720, WR 139021, WR-139021, WR139021, Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518, B-518, B518, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamide Monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR 138719, WR- 138719, WR-138719, WR138719, Cytarabine, .beta.-Cytosine arabinoside, 1-.beta.-D-Arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-.beta.-D-Arabinofuranosylcytosine, 1-Beta-D-arabinofuranosyl-4-amino-2(1H)pyrimidinone, 1-Beta-D-arabinofuranosylcytosine, 1.beta.-D-Arabinofuranosylcytosine, 2(1H)-Pyrimidinone, 4-Amino-1-beta-D-arabinofuranosyl-, 2(1H)-Pyrimidinone, 4-amino-1.beta.-D-arabinofuranosyl-, Alexan, Ara-C, ARA-cell, Arabine, Arabinofuranosylcytosine, Arabinosylcytosine, Aracytidine, Aracytin, Aracytine, Beta-Cytosine Arabinoside, CHX-3311, Cytarabinum, Cytarbel, Cytosar, Cytosine Arabinoside, Cytosine-.beta.-arabinoside, Cytosine-beta-arabinoside, Erpalfa, Starasid, Tarabine PFS, U 19920, U-19920, Udicil, WR-28453, Etoposide, Demethyl Epipodophyllotoxin Ethylidine Glucoside, EPEG, Lastet, Toposar, Vepesid, VP 16, VP 16-213, VP 16213, VP-16, VP-16-213, VP-16213, VP16, VP16213, Ibrutinib, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765, Laboratory Biomarker Analysis, Melphalan, Alanine Nitrogen Mustard, CB-3025, L-PAM, L-Phenylalanine Mustard, L-Sarcolysin, L-Sarcolysin Phenylalanine mustard, L-Sarcolysine, Melphalan for Injection-Hepatic Delivery System, Melphalanum, Phenylalanine Mustard, Phenylalanine Nitrogen Mustard, Sarcoclorin, Sarkolysin, WR-19813, Pharmacogenomic Study, PHARMACOGENOMIC, Placebo Administration
National Cancer Institute (NCI)
Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type, Refractory Diffuse Large B-Cell Lymphoma Activated B-Cell Type
06/24
12/25
NCT04212013: A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

Active, not recruiting
3
23
US
Ibrutinib, Rituximab, Placebo
Memorial Sloan Kettering Cancer Center, Pharmacyclics LLC.
Marginal Zone Lymphoma
03/27
03/27
SYMPATICO, NCT03112174 / 2017-000129-12: Study of Ibrutinib Combined With Venetoclax in Subjects With Mantle Cell Lymphoma (MCL)

Jan 2023 - Dec 2023: Data from SYMPATICO trial in combination with Venclexta for r/r MCL
Completed
3
366
Europe, Canada, US, RoW
Ibrutinib, Venetoclax, Placebo Oral tablet to match Venetoclax
Pharmacyclics LLC., Janssen Research & Development, LLC
Mantle-Cell Lymphoma
06/24
06/24
BRUIN-MCL-321, NCT04662255 / 2020-004553-72: Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL)

Active, not recruiting
3
500
Europe, Canada, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Ibrutinib, Imbruvica, Acalabrutinib, Calquence, Zanubrutinib, Brukinsa
Loxo Oncology, Inc., Eli Lilly and Company
Lymphoma, Mantle-Cell
01/27
04/28
INCA034176-355, NCT06821542: A Study to Evaluate Axatilimab Versus Best Available Therapy in Participants With Chronic Graft Versus Host Disease After at Least 2 Prior Lines of Systemic Therapy

Active, not recruiting
3
9
Europe, RoW
INCA034176, Axatilimab, Best Available Therapy (BAT), BAT could include:, • Calcineurin inhibitor (cyclosporine or tacrolimus), • Extracorporeal photopheresis (ECP), • Mycophenolate mofetil (MMF), • A mammalian target of rapamycin (mTOR) inhibitor (everolimus or sirolimus), • Rituximab, • Pentostatin, • Proteasome inhibitors, • Imatinib, • Ibrutinib
Incyte Corporation
Chronic Graft-versus-host-disease
05/28
11/32
PERSPECTIVE, NCT02947347 / 2016-003202-14: Study of Ibrutinib and Rituximab in Treatment Naïve Follicular Lymphoma

Completed
3
445
Europe, Canada, US, RoW
ibrutinib, Imbruvica, placebo to match ibrutinib, rituximab
Pharmacyclics LLC.
Follicular Lymphoma
02/24
06/25
NCT05431179 / 2022-001547-25: A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Withdrawn
3
365
NA
Zilovertamab, Cirmtuzumab, UC961, Ibrutinib, Imbruvica, Placebo
Oncternal Therapeutics, Inc, Pharmacyclics LLC.
Lymphoma, Mantle-Cell, Lymphoma, Lymphoproliferative Disorders, Lymphatic Diseases, Immunoproliferative Disorders, Immune System Diseases, Lymphoma, Non-Hodgkin, Lymphoma, B-Cell
11/26
12/26
NCT01804686 / 2012-004225-24: A Long-term Extension Study of PCI-32765 (Ibrutinib)

Recruiting
3
700
Europe, Canada, Japan, US, RoW
Ibrutinib, PCI-32765
Janssen Research & Development, LLC, Pharmacyclics LLC.
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, Chronic Graft Versus Host Disease
12/26
01/27
CLL17, NCT04608318 / 2019-003854-99: Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients with Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

Active, not recruiting
3
897
Europe, RoW
Ibrutinib, Imbruvica, Venetoclax, ABT-199, Venclyxto, Obinutuzumab, GA101, Gazyvaro
German CLL Study Group, Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Nordic CLL Study Group (NCLLSG), Swiss Group for Clinical Cancer Research (SAKK), Cancer Trials Ireland, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), Grupo Español de Leucemia Linfocítica Crónica (GELLC), The Israeli CLL Study Group (ICLLSG), Janssen Pharmaceutica N.V., Belgium, AbbVie, Hoffmann-La Roche
Chronic Lymphoid Leukemia
09/27
09/27
A041702, NCT03737981: Testing the Addition of a New Anti-cancer Drug, Venetoclax, to the Usual Treatment (Ibrutinib and Obinutuzumab) in Untreated, Older Patients With Chronic Lymphocytic Leukemia

Active, not recruiting
3
465
US
Ibrutinib, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765, Obinutuzumab, Anti-CD20 Monoclonal Antibody R7159, GA 101, GA-101, GA101, Gazyva, huMAB(CD20), R 7159, R-7159, R7159, RO 5072759, RO-5072759, RO5072759, Observation Activity, Observation, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
01/25
06/26
BRUIN-CLL-314, NCT05254743 / 2021-003206-41: A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Hourglass Sep 2025 - Dec 2025 : Regulatory submission for 1L CLL/SLL
Recruiting
3
662
Europe, Canada, Japan, US, RoW
Pirtobrutinib, LOXO-305, LY3527727, Ibrutinib
Loxo Oncology, Inc., Eli Lilly and Company
Chronic Lymphocytic Leukemia, Leukemia, Lymphocytic, Leukemia, B-cell, Small Lymphocytic Lymphoma
06/25
01/28
NCT03701282: Assessing the Ability of Combination Treatment With Venetoclax to Permit Time Limited Therapy in Chronic Lymphocytic Leukemia

Active, not recruiting
3
720
US, RoW
Biospecimen Collection, Biological Sample Collection, Biospecimen Collected, Specimen Collection, Bone Marrow Biopsy, Biopsy of Bone Marrow, Biopsy, Bone Marrow, Computed Tomography, CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, Diagnostic CAT Scan, Diagnostic CAT Scan Service Type, tomography, Ibrutinib, BTK Inhibitor PCI-32765, CRA 032765, CRA-032765, CRA032765, Imbruvica, PCI 32765, PCI-32765, PCI32765, Obinutuzumab, Anti-CD20 Monoclonal Antibody R7159, GA 101, GA-101, GA101, Gazyva, huMAB(CD20), R 7159, R-7159, R7159, RO 5072759, RO-5072759, RO5072759, Quality-of-Life Assessment, Quality of Life Assessment, Venetoclax, ABT 199, ABT-0199, ABT-199, ABT199, GDC 0199, GDC-0199, GDC0199, RG7601, Venclexta, Venclyxto
National Cancer Institute (NCI)
Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
05/28
05/28
2015-000832-13: Ibrutinib for untreated mantle cell lymphoma

Ongoing
2/3
400
Europe
Ibrutinib, Bendamustine hydrochloride, Cyclophosphamide, Doxorubicin hydrochloride, Vincristine sulphate, Prednisolone, Capsule, hard, Lyophilisate for solution for infusion, Powder for solution for infusion, Solution for infusion, Solution for injection, Tablet, Ibrutinib, doxorubicin
University Hospitals Plymouth NHS Trust, Plymouth Hospitals NHS Trust, Cancer Research UK, Janssen Pharmaceutica NV
Untreated symptomatic Mantle Cell Lymphoma, Untreated symptomatic Mantle Cell Lymphoma, Diseases [C] - Cancer [C04]
 
 
NCT02801578: A Study of Different Doses of Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)

Completed
2/3
11
US
Ibrutinib, PCI-32765, Imbruvica
M.D. Anderson Cancer Center
Chronic Lymphocytic Leukemia
01/19
01/19
2019-001261-33: Study of Rituximab and Ibrutinib (RI) versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as initial therapy for Waldenström's macroglobulinaemia

Not yet recruiting
2/3
148
Europe
Ibrutinib, Rituximab, Dexamethasone, Cyclophosphamide, Capsule, hard, Concentrate for solution for infusion, , Ibrutinib, Rituximab, Dexamethasone, Cyclophosphamide
University College London
Waldenström's macroglobulinaemia, a blood cancer, Diseases [C] - Cancer [C04]
 
 
2018-003526-88: Efficacy and safety of Carfilzomib in combination with Ibrutinib for patients with Waldenström's macroglobulinemia (CZAR-1) Wirksamkeit und Sicherheit von Carfilzomib in Kombination mit Ibru-tinib oder Ibrutinib alleine bei Patienten mit Morbus Waldenström

Terminated
2/3
184
Europe
Kyprolis, [Imbruvica], [Kyprolis], Powder for solution for infusion, Capsule, hard, Kyprolis, Imbruvica
University Hospital Ulm, UNIVERSITäTSKLINIK ULM, Amgen Inc., Janssen Pharmaceutica NV
Waldenström's Macroglobulinemia, Waldenström's Macroglobulinemia, Diseases [C] - Cancer [C04]
 
 
NCT03642236: Combination of BTK Inhibitor Overcomes Drug-resistance in Refractory/Relapsed FLT3 Mutant AML

Enrolling by invitation
2/3
122
RoW
Ibrutinib
Nanfang Hospital of Southern Medical University
FLT3-ITD Mutation, Acute Myeloid Leukemia, Brutons Tyrosine Kinase
08/22
09/23
2022-000364-21: A Study of Ibrutinib in Combination With Rituximab Versus Lenalidomide Plus Rituximab or Bortezomib Plus Rituximab, in Relapsed/Refractory Mantle Cell Lymphoma Estudio de ibrutinib en combinación con rituximab frente a lenalidomida más rituximab o bortezomib más rituximab para el tratamiento de linfoma de células del manto recidivante/refractario.

Completed
2/3
490
Europe, RoW
ibrutinib, JNJ-54179060, Capsule, hard, Concentrate for solution for infusion, Powder for solution for injection, IMBRUVICA, Ruxience, Lenalidomide Accord, VELCADE
Janssen-Cilag International NV, Janssen Research & Development, LLC
Relapsed or Refractory Mantle Cell Lymphoma Linfoma de células del manto recidivante o refractario, Blood Cancer Cáncer de sangre, Diseases [C] - Cancer [C04]
 
 
RAINBOW, NCT04061512: Rituximab and Ibrutinib (RI) Versus Dexamethasone, Rituximab and Cyclophosphamide (DRC) as Initial Therapy for Waldenström's Macroglobulinaemia

Recruiting
2/3
148
Europe
Dexamethasone, cyclophosphamide, rituximab, Rituximab, ibrutinib
University College, London, Janssen-Cilag Ltd.
Waldenstrom Macroglobulinemia
03/30
03/30

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