A Phase 2, Open-Label, Multicenter, Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465)

JRCT ID: jRCT2021220038

Registered date:06/01/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: B-Cell Malignancies
• Date of first enrollment: 30/09/2022
• Target sample size: 31
• Countries of recruitment: U.S.A,Japan,Belgium,Japan,Czechia,Japan,Denmark,Japan,France,Japan,Israel,Japan,Italy,Japan,Spain,Japan,Sweden,Japan,United Kingdom,Japan,Austria,Japan,Hungary,Japan,Korea,Japan,Norway,Japan,Poland,Japan,Turkey,Japan
• Study type: Interventional

Intervention(s)

- Parsaclisib
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.

- Parsaclisib + Itacitinib
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.

- Parsaclisib + Ruxolitinib
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and the same dose of ruxolitinib that was provided in the parent Protocol at the time of the rollover.

- Parsaclisib + Ibrutinib
Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 140 mg of ibrutinib as that provided in the parent Protocol at the time of the rollover.

Outcome(s)

• Primary Outcome: Incidence of Treatment-Emergent Adverse Events

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Currently enrolled and receiving treatment in an Incyte-sponsored clinical study of parsaclisib.
2. Currently tolerating treatment in the parent Protocol.
3. Currently receiving clinical benefit from treatment with parsaclisib as monotherapy or in combination therapy with Itacitinib, ruxolitinib, or ibrutinib as determined by the investigator.
4. Has at least stable disease, as determined by the investigator.
5. Has demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
6. Willingness and ability to comply with scheduled visits, treatment plans, including PJP prophylaxis, and any other study procedures indicated in this Protocol.
7. Willingness to avoid pregnancy or fathering children
8. Ability to comprehend and willingness to sign an ICF

Exclude criteria

1. Has been permanently discontinued from study treatment in the parent Protocol for any reason.
2. Able to access parsaclisib as monotherapy or in combination with itacitinib, ruxolitinib, or ibrutinib therapy outside a clinical study.
3. Participants with an uncontrolled intercurrent illness or any concurrent condition that, in the investigator's opinion, would jeopardize the safety of the participant or compliance with the Protocol.
4. Pregnant or breastfeeding women.

Related Information

• Primary Sponsor: Ueda Eiji
• Secondary ID(s): NCT04509700