CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 88 enrolled
Drug / intervention
Parsaclisib +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02018861
NCT02018861Phase 2Completed
CompareCT.gov

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)

Incyte Corporation·interventional·Posted Dec 23, 2013·Updated Sep 28, 2023

In Brief

A Phase 2 clinical trial evaluating Parsaclisib, Itacitinib, and 4 other interventions for B-Cell Malignancies. Completed, enrolled 88 participants across 7 sites.

Detailed Summary

Open-label, dose-escalation study in subjects with previously treated B-cell malignancies to find maximum tolerated dose (MTD) or pharmacologic active dose of a PI3Kδ inhibitor, parsaclisib, as monotherapy and in combination with: itacitinib (INCB039110), a JAK1 inhibitor; rituximab; and rituximab, ifosfamide, carboplatin, and etoposide. Parsaclisib inhibits PI3Kδ, a protein involved in growth and survival of B-cell cancer cells.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsB-Cell Malignancies
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 23, 2013
Enrollment StartSep 22, 2016
Primary CompletionApr 12, 2021
TodayJul 2, 2026
Enrollment to primary: 4.6 yearsPosted 12.5 years ago

Interventions

Parsaclisibdrug

Itacitinibdrug

Rituximabdrug

Ifosfamidedrug

Carboplatindrug

Etoposidedrug