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    DRUG:

    itacitinib (INCB039110)

    i
    Other names: INCB039110, INCB-039110, INCB 39110, INCB39110, INCB-39110, INCB 039110, IBI-377, IBI377, IBI 377
    Company:
    Incyte, Innovent Biologics
    Drug class:
    JAK1 inhibitor
    Related drugs:
    5d
    Phase 1B pilot study of itacitinib with alemtuzumab in patients with T-cell prolymphocytic leukemia. (PubMed, Blood Neoplasia)
    Continued studies evaluating JAK inhibitors in patients with T-PLL are warranted. This trial was registered at www.clinicaltrials.gov as #NCT03989466.
    Clinical • P1 data • Journal
    |
    JAK3 (Janus Kinase 3) • STAT5B (Signal Transducer And Activator Of Transcription 5B) • TCL1A (TCL1 Family AKT Coactivator A) • IL2RG (Interleukin 2 Receptor Subunit Gamma)
    |
    Campath (alemtuzumab) • itacitinib (INCB039110)
    24d
    HLH-JAK: Treatment of Non Severe Hemophagocytosis Lymphohistiocytosis With ITACITINIB (clinicaltrials.gov)
    P2, N=35, Completed, Assistance Publique - Hôpitaux de Paris | Recruiting --> Completed | N=63 --> 35 | Trial completion date: Feb 2024 --> Oct 2025 | Trial primary completion date: Nov 2023 --> Apr 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110)
    2ms
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Oct 2026 --> Jan 2027 | Trial primary completion date: Oct 2025 --> Jan 2026
    Trial completion date • Trial primary completion date
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    2ms
    Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1, N=8, Terminated, M.D. Anderson Cancer Center | Trial completion date: May 2027 --> Oct 2025 | Active, not recruiting --> Terminated | Trial primary completion date: May 2027 --> Oct 2025; <75% participation
    Trial completion date • Trial termination • Trial primary completion date
    |
    itacitinib (INCB039110)
    3ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, M.D. Anderson Cancer Center | Phase classification: P1 --> P2
    Phase classification
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)
    4ms
    Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov)
    P1, N=8, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: May 2025 --> May 2027 | Trial primary completion date: May 2025 --> May 2027
    Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110)
    4ms
    Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov)
    P1, N=32, Active, not recruiting, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cyclophosphamide • itacitinib (INCB039110)
    6ms
    Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov)
    P2, N=27, Recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2025 --> Oct 2025
    Trial completion date • Trial primary completion date
    |
    JAK1 (Janus Kinase 1) • CRP (C-reactive protein)
    |
    Yescarta (axicabtagene ciloleucel) • itacitinib (INCB039110)
    7ms
    A phase 2 study of itacitinib alone or in combination with low-dose ruxolitinib in patients with myelofibrosis. (PubMed, Leuk Res)
    Overall, 8 of 23 patients enrolled achieved SVR at week 24; larger average changes in SVR at week 12 were observed for itacitinib monotherapy vs. the combination. No unexpected safety signals were observed.
    P2 data • Journal
    |
    JAK1 (Janus Kinase 1)
    |
    Jakafi (ruxolitinib) • itacitinib (INCB039110)
    8ms
    Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov)
    P1, N=121, Active, not recruiting, Incyte Corporation | Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026
    Trial completion date • Trial primary completion date
    |
    itacitinib (INCB039110) • dezapelisib (INCB040093)
    8ms
    NCI-2022-03765: Adding Itacitinib to Cyclophosphamide and Tacrolimus for the Prevention of Graft Versus Host Disease in Patients Undergoing Hematopoietic Stem Cell Transplants (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, City of Hope Medical Center | Recruiting --> Active, not recruiting | N=50 --> 20
    Enrollment closed • Enrollment change
    |
    cyclophosphamide • itacitinib (INCB039110)
    10ms
    Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov)
    P1, N=31, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Apr 2025 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    cyclophosphamide • fludarabine IV • thiotepa • busulfan • itacitinib (INCB039110)