Trial Profile
A Phase 1/2, Open-Label, Dose Escalation, Safety and Tolerability Study of INCB050465 and Iitacitinib in Subjects With Previously Treated B-Cell Malignancies (CITADEL-101)
Status:
Completed
Phase of Trial:
Phase I/II
Latest Information Update: 30 Jun 2022
Price :
$35
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At a glance
- Drugs Itacitinib (Primary) ; Parsaclisib (Primary) ; Carboplatin; Etoposide; Ifosfamide; Rituximab
- Indications B-cell lymphoma; 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
- 01 Jun 2022 The protocol was amended to allow patients to receive Parsaclisib 5 mg QD, 30 mg QD, 45 mg QD, Parsaclisib 20 mg + itacitinib (INCB039110) 300 mg, Parsaclisib 30 mg + itacitinib (INCB039110) 300 mg, Parsaclisib 20 mg QD + R-ICE (placebo), and Parsaclisib 15 mg QD + R-ICE (placebo), according to ClinicalTrials.gov record. Accordingly, the number of arms were increased from 3 to 10.
- 01 Jun 2022 The primary endpoint Safety and tolerability assessed by summary of Adverse Events (AEs), clinical lab assessments, physical exam results, and 12-lead ECGs for Parsaclisib as monotherapy and as a combination therapy was changed to Number of Participants With Treatment-emergent Adverse Events (TEAEs), according to ClinicalTrials.gov record.
- 03 May 2021 Status changed from active, no longer recruiting to completed.