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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)
(Protocol No.: INCB 50465-801)

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)

Suzukawa Kazumi

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

jpmedinfo@incyte.com

Medical Information Center Operations

Incyte Biosciences Japan G.K.

Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan

+81-120-094-139

jpmedinfo@incyte.com

Not Recruiting

Sept. 30, 2022

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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

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.

Both

B-Cell Malignancies

- 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.

Incidence of Treatment-Emergent Adverse Events

+81-22-717-7056

Yes

Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

U.S.A/Belgium/Czechia/Denmark/France/Israel/Italy/Spain/Sweden/United Kingdom/Austria/Hungary/Korea/Norway/Poland/Turkey