CITADEL-302
Research type
Research Study
Full title
A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study of Parsaclisib Plus Investigator’s Choice of Either Rituximab or Obinutuzumab in Participants With Relapsed or Refractory Follicular Lymphoma and Marginal Zone Lymphoma (CITADEL-302)
IRAS ID
1004304
Contact name
Aaron Packman
Contact email
Sponsor organisation
Incyte Corporation
Eudract number
2020-004056-15
Clinicaltrials.gov Identifier
Research summary
The purpose of this clinical study is to collect information about the safety and effects of an investigational medicine called parsaclisib and to compare it to placebo. The participants are adults who have follicular lymphoma (FL) or marginal zone lymphoma (MZL) that has relapsed or does not respond to medication.
The study doctor will first choose which already approved treatment (rituximab or obinutuzumab) suits each participant the best. Then the participants will be randomly assigned (like flipping a coin) to receive either parsaclisib or placebo. The participants and the study staff will not know if the participants are getting parsaclisib or placebo.
Parsaclisib has been studied before and the studies have shown that it has extended the survival time of participants with FL and MZL. Its side effects have been assessed and based on the results, further research on parsaclisib is warranted.
Both rituximab and obinutuzumab are given as infusions (drips) in 28-day cycles. Rituximab is given for up to 5 cycles and obinutuzumab for up to 30 cycles. Parsaclisib and placebo are taken as oral tablets once a day. The tablets are taken until certain criteria to stop them have been met.
During the study, participants will have tests and procedures that are part of their normal cancer care; these may be done more often because of study participation. They will also have some tests and procedures that are being performed as part of the study for research purposes, such as biopsies (of lymph nodes, bone marrow and/or tumour tissue), imaging of different types, or for safety purposes.
Participants can be in this study for up to 10 years. The plan is to recruit about 416 participants globally (Europe, Asia Pacific, and North America) and about 7 in the UK.
It is unknown whether the participants benefit from being in the study. They may improve, but this cannot be guaranteed.
This study is sponsored (funded by) Incyte Corporation, a pharmaceutical company from USA.REC name
South Central - Berkshire B Research Ethics Committee
REC reference
22/SC/0008
Date of REC Opinion
28 Jun 2022
REC opinion
Further Information Unfavourable Opinion