parsaclisib (INCB50465) / Incyte 
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26 Trials

   

 
Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
parsaclisib (INCB50465) / Incyte
2020-003415-98: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
212
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
2020-003130-21: A phase 3 study of parsaclisib plus ruxolitinib in patients with myelofibrosis

Ongoing
3
440
Europe
parsaclisib, INCB050465, Tablet
Incyte Corporation, Incyte Corporation
myelofibrosis, myelofibrosis, Diseases [C] - Cancer [C04]
 
 
LIMBER-313, NCT04551066: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis

Active, not recruiting
3
252
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
11/24
LIMBER-304, NCT04551053: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib

Oct 2023 - Dec 2023: Data from LIMBER-304 trial n combination with ruxolitinib for myelofibrosis
Terminated
3
177
Europe, Japan, US, RoW
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
08/23
08/24
NCT04816578: To Evaluate the Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis (LIMBER-313)

Recruiting
3
440
US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
09/23
02/26
NCT05073458 / 2021-002844-66: Study of the Efficacy and Safety of Parsaclisib in Participants With Primary Warm Autoimmune Hemolytic Anemia

Terminated
3
13
Europe, Canada, Japan, US, RoW
parsaclisinib, INCB050465, placebo
Incyte Corporation, Incyte Corporation
Warm Autoimmune Hemolytic Anemia (wAIHA)
10/23
04/24
NCT04816565: To Evaluate Efficacy and Safety of Parsaclisib and Ruxolitinib in Participants With Myelofibrosis Who Have Suboptimal Response to Ruxolitinib (LIMBER-304)

Not yet recruiting
3
212
Europe, US
parsaclisib, INCB050465, ruxolitinib, Jakafi, Jakavi, placebo
Incyte Corporation
Myelofibrosis, Primary Myelofibrosis, Post Essential Thrombocythemia Myelofibrosis, Post Polycythemia Vera Myelofibrosis
11/23
12/23
2019-004948-30: A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With Advanced Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Not yet recruiting
2
200
Europe
parsaclisib 20 mg Tablets, parsaclisib 5 mg Tablets, parsaclisib 2.5 mg Tablets, parsaclisib 1 mg Tablets, INCB050465 20 mg Tablets, INCB050465 5 mg Tablets, INCB050465 2.5 mg Tablets, INCB050465 1 mg Tablets, Tablet, IMBRUVICA 140 mg hard capsules
Incyte Corporation, INCYTE CORPORATION, Incyte Corporation
Advanced malignancies, Advanced malignancies, Diseases [C] - Cancer [C04]
 
 
CITADEL-204, NCT03144674 / 2017-000970-12: A Study of INCB050465 in Subjects With Relapsed or Refractory Marginal Zone Lymphoma

Checkmark Primary analysis data from CITADEL-204 trial for r/r MZL at ASH 2021
Dec 2021 - Dec 2021: Primary analysis data from CITADEL-204 trial for r/r MZL at ASH 2021
Checkmark Data from CITADEL-204 trial for r/r MZL at ASH 2020
Dec 2020 - Dec 2020: Data from CITADEL-204 trial for r/r MZL at ASH 2020
Completed
2
110
Europe, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
01/21
05/24
CITADEL-203, NCT03126019 / 2017-001624-22: A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Checkmark Results from CITADEL-203 trial for r/r follicular lymphoma
Dec 2021 - Dec 2021: Results from CITADEL-203 trial for r/r follicular lymphoma
Checkmark Data from CITADEL-203 trial for relapsed/refractory follicular lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from CITADEL-203 trial for relapsed/refractory follicular lymphoma at ASH 2020
Completed
2
126
Europe, Canada, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
02/21
06/24
CITADEL-205, NCT03235544 / 2017-003148-19: A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Checkmark Data from cohort 1 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from cohort 1 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Checkmark Data from cohort 2 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Dec 2020 - Dec 2020: Data from cohort 2 of CITADEL-205 trial for r/r mantle cell lymphoma at ASH 2020
Completed
2
162
Europe, US, RoW
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
03/21
04/24
CIBI376A201, NCT04298879: IBI376 in Patients With Relapsed or Refractory Follicular Lymphoma/Marginal Zone Lymphoma

Completed
2
81
RoW
IBI376, Parsaclisib
Innovent Biologics (Suzhou) Co. Ltd.
Indolent Non-hodgkin Lymphoma
07/21
11/23
AIHA, NCT03538041 / 2017-003652-22: A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia

Completed
2
25
Europe, US
Parsaclisib, INCB050465
Incyte Corporation
Autoimmune Hemolytic Anemia
08/21
04/24
NCT04434937: Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Completed
2
42
Japan
parsaclisib, INCB050465
Incyte Biosciences Japan GK
Lymphoma
02/23
10/23
NCT05073250: IBI376 Plus Rituximab in Patients With Untreated Indolent Lymphoma.

Recruiting
2
40
RoW
IBI376, PI3Kδ inhibitor, Rituximab, Anti-cluster of differentiation antigen 20 (CD20) monoclonal antibody
Chinese PLA General Hospital
Inert Non Hodgkin's Lymphoma
12/23
11/24
ChiCTR2100047979: Sintilimab combine IBI376 for the treatment of relapsed or refractory peripheral T-cell lymphoma(PTCL): a prospective, muliticenter, open label phase I/II study

Not yet recruiting
2
60
 
Sintilimab+IBI376
Jiangsu Province Hospital; Jiangsu Province Hospital, Cinda Biopharmaceutical (Suzhou) Co., LTD
peripheral T-cell lymphoma
 
 
NCT04509700: Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

Active, not recruiting
2
112
Europe, Japan, US, RoW
Parsaclisib, INCB050465, parsaclisib + itacitinib, INCB39110, parsaclisib + ruxolitinib, INCB018424, parsaclisib + ibrutinib
Incyte Corporation
B-Cell Malignancies
09/27
09/27
topMIND, NCT04809467 / 2020-005591-35: A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Hourglass Jan 2023 - Dec 2023 : Proof-of-concept data from TopMIND trial in combination with parsaclisib for r/r NHL or CLL
Completed
1/2
54
Europe, US
tafasitamab, INCMOR00208, parsaclisib, INCB050465
Incyte Corporation
Chronic Lymphocytic Leukemia, Non Hodgkin Lymphoma
10/24
10/24
NCT05083208: PI3Kδ Inhibitor Parsaclisib Combined With Chidamide for the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma

Recruiting
1/2
28
RoW
Parsaclisib, IBI376, PI3K inhibitor, Chidamide
Henan Cancer Hospital
Peripheral T-Cell Lymphoma
06/24
01/27
NCT05238064: Parsaclisib in Combination With CHOP in Participants With Previously Untreated PTCL

Not yet recruiting
1/2
30
NA
Parsaclisib, IBI376, CHOP, Cyclophosphamide, doxorubicin, vincristine and prednison
Fudan University
PI3Kδ Inhibitor, Parsaclisib, CHOP, PTCL
03/25
12/25
J-MIND, NCT04661007: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL)

Recruiting
1/2
65
Japan
tafasitamab, INCMOR00208, MOR00208, Xmab5574, lenalidomide, parsaclisib, R-CHOP
Incyte Biosciences Japan GK
Non Hodgkins Lymphoma, Diffuse Large B-cell Lymphoma
05/25
07/26
NCT03314922: A Study of INCB050465 in Japanese Subjects With Previously Treated B-Cell Lymphoma (CITADEL-111)

Completed
1b
17
Japan
Parsaclisib, INCB050465
Incyte Corporation
Lymphoma
05/20
03/23
INCMGA 0012-102, NCT03589651: INCMGA00012 in Combination With Other Therapies in Patients With Advanced Solid Tumors

Completed
1b
83
US
Retifanlimab, Epacadostat, INCB024360, INCMGA00012, INCB050465
Incyte Corporation
Unresectable or Metastatic Solid Tumors
11/22
11/22
NCT04774068: Romidepsin and Parsaclisib for the Treatment of Relapsed or Refractory T-Cell Lymphomas

Active, not recruiting
1
5
US
Parsaclisib, (4R)-4-(3-((1S)-1-(4-Amino-3-methyl-1H-pyrazolo(3,4-d)pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one, INCB 50465, INCB-50465, INCB050465, INCB50465, WHO 10589, Romidepsin, Antibiotic FR 901228, Depsipeptide, FK228, FR901228, Istodax, N-[(3S,4E)-3-Hydroxy-7-mercapto-1-oxo-4-heptenyl]-D-valyl-D-cysteinyl-(2Z)-2-amino-2-butenoyl-L-valine, (4->1) Lactone, Cyclic
Walter Hanel
Recurrent Anaplastic Large Cell Lymphoma, Recurrent Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Recurrent Transformed Mycosis Fungoides, Refractory Anaplastic Large Cell Lymphoma, Refractory Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma, Refractory Primary Cutaneous T-Cell Non-Hodgkin Lymphoma, Refractory Transformed Mycosis Fungoides, T-Cell Non-Hodgkin Lymphoma
12/24
12/24
NCT04323956: Parsaclisib Plus the Standard Drug Therapy in Patients with Newly Diagnosed, High Risk Diffuse Large B-cell Lymphoma

Active, not recruiting
1
50
US
Cyclophosphamide, (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, 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, Asta B 518, B-518, WR-138719, Doxorubicin Hydrochloride, 5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex, Parsaclisib, (4R)-4-(3-((1S)-1-(4-Amino-3-methyl-1H-pyrazolo(3,4-d)pyrimidin-1-yl)ethyl)-5-chloro-2-ethoxy-6-fluorophenyl)pyrrolidin-2-one, IBI376, INCB 50465, INCB-50465, INCB050465, INCB50465, WHO 10589, Pegfilgrastim, Filgrastim SD-01, filgrastim-SD/01, Fulphila, HSP-130, Jinyouli, Neulasta, Neulastim, Nyvepria, PEG-filgrastim, Pegcyte, Pegfilgrastim Biosimilar HSP-130, Pegfilgrastim Biosimilar Nyvepria, Pegfilgrastim Biosimilar Pegcyte, Pegfilgrastim Biosimilar PF-06881894, Pegfilgrastim Biosimilar Udenyca, Pegfilgrastim Biosimilar Ziextenzo, pegfilgrastim-apgf, pegfilgrastim-bmez, pegfilgrastim-cbqv, Pegfilgrastim-jmdb, PF-06881894, SD-01, SD-01 sustained duration G-CSF, Udenyca, Ziextenzo, Neupopeg, Pegylated G-CSF, Pegylated GCSF, Pegylated Granulocyte Colony Stimulating Factor, Polatuzumab Vedotin, ADC DCDS4501A, Antibody-Drug Conjugate DCDS4501A, DCDS4501A, FCU 2711, polatuzumab vedotin-piiq, Polivy, RG7596, Ro 5541077-000, Prednisone, .delta.1-Cortisone, 1, 2-Dehydrocortisone, Adasone, Cortancyl, Dacortin, DeCortin, Decortisyl, Decorton, Delta 1-Cortisone, Delta-Dome, Deltacortene, Deltacortisone, Deltadehydrocortisone, Deltasone, Deltison, Deltra, Econosone, Lisacort, Meprosona-F, Metacortandracin, Meticorten, Ofisolona, Orasone, Panafcort, Panasol-S, Paracort, Perrigo Prednisone, PRED, Predicor, Predicorten, Prednicen-M, Prednicort, Prednidib, Prednilonga, Predniment, Prednisone Intensol, Prednisonum, Prednitone, Promifen, Rayos, Servisone, SK-Prednisone, Rituximab, ABP 798, BI 695500, C2B8 Monoclonal Antibody, Chimeric Anti-CD20 Antibody, CT-P10, IDEC-102, IDEC-C2B8, IDEC-C2B8 Monoclonal Antibody, MabThera, Monoclonal Antibody IDEC-C2B8, PF-05280586, Riabni, Rituxan, Rituximab ABBS, Rituximab ARRX, Rituximab Biosimilar ABP 798, Rituximab Biosimilar BI 695500, Rituximab Biosimilar CT-P10, Rituximab Biosimilar GB241, 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-pvvr, RTXM83, Ruxience, Truxima, Ikgdar, Mabtas, Vincristine Sulfate, Kyocristine, Leurocristine Sulfate, Leurocristine, sulfate, Oncovin, Vincasar, Vincosid, Vincrex, Vincristine, sulfate
Mayo Clinic, National Cancer Institute (NCI)
Ann Arbor Stage II Diffuse Large B-Cell Lymphoma, Ann Arbor Stage II Follicular Lymphoma, Ann Arbor Stage II Marginal Zone Lymphoma, Ann Arbor Stage III Diffuse Large B-Cell Lymphoma, Ann Arbor Stage III Follicular Lymphoma, Ann Arbor Stage III Marginal Zone Lymphoma, Ann Arbor Stage IV Diffuse Large B-Cell Lymphoma, Ann Arbor Stage IV Follicular Lymphoma, Ann Arbor Stage IV Marginal Zone Lymphoma, Diffuse Large B-Cell Lymphoma, High Grade B-Cell Lymphoma with MYC and BCL2 And/or BCL6 Rearrangements, High Grade B-Cell Lymphoma with MYC and BCL2 or BCL6 Rearrangements, High Grade B-Cell Lymphoma with MYC, BCL2, and BCL6 Rearrangements, Indolent Non-Hodgkin Lymphoma
05/26
05/27
NCT05867030: Parsaclisib in Patients With Relapsed or Refractory Follicular Lymphoma

Withdrawn
1
560
NA
lenalidomide, Lainamei, rituximab, Halpryza, parsaclisib, IBI376
Innovent Biologics (Suzhou) Co. Ltd.
Follicular Lymphoma
08/29
04/33

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