A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib (INCB039110) in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

Trial Profile

A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Itacitinib (INCB039110) in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)

Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 10 Aug 2018

At a glance

  • Drugs Itacitinib (Primary) ; Parsaclisib (Primary) ; Carboplatin; Etoposide; Ifosfamide; Rituximab
  • Indications Chronic lymphocytic leukaemia; Diffuse large B cell lymphoma; Follicular lymphoma; Hairy cell leukaemia; Hodgkin's disease; Mantle-cell lymphoma; Marginal-zone-B-cell-lymphoma; Non-Hodgkin's lymphoma; Waldenstrom's macroglobulinaemia
  • Focus Adverse reactions
  • Acronyms CITADEL-101
  • Sponsors Incyte Corporation
  • Most Recent Events

    • 08 Aug 2018 Planned primary completion date changed from 1 Jun 2018 to 1 Dec 2018.
    • 12 Dec 2017 According to results presented at the 59th Annual Meeting and Exposition of the American Society of Hematology, the treatment schedule was modified in November 2016 to introduce once-weekly (QW) dosing (INCB050465) after week 9, based on emerging PK, safety, and efficacy data.
    • 12 Dec 2017 Results (n=72; data cut-off: 20 May 2017) assessing saftey and efficacy of INCB050465 monotherapy in patients with relapsed or refractory B-cell malignancies , presented at the 59th Annual Meeting and Exposition of the American Society of Hematology.
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