Sept. 05, 2021 |
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Aug. 07, 2022 |
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jRCT2031210296 |
To Evaluate Efficacy and Safety of Parsaclisib Plus Either Rituximab or Obinutuzumab in R/R Follicular Lymphoma (FL) and Marginal Zone Lymphoma (MZL) (CITADEL-302) |
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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) |
Ueda Eiji |
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Incyte Biosciences Japan G.K. |
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Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan |
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+81-120-094-139 |
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jpmedinfo@incyte.com |
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Medical Information Center |
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Incyte Biosciences Japan G.K. |
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Tokyo Midtown Hibiya, 1-1-2 Yurakucho, Chiyoda-ku, Tokyo, Japan |
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+81-120-094-139 |
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jpmedinfo@incyte.com |
Complete |
Dec. 30, 2022 |
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0 | ||
Interventional |
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randomized controlled trial |
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double blind |
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active control |
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parallel assignment |
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treatment purpose |
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- Male and female participants aged 18 years or older (Japan, aged 20 years or older). |
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- Women who are pregnant or breastfeeding. |
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18age old over | ||
No limit | ||
Both |
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Follicular Lymphoma (FL) , Marginal Zone Lymphoma (MZL) |
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Parallel Assignment |
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Progression Free Survival (PFS) in R/R FL and MZL participants |
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1. Progression Free Survival (PFS) in R/R FL participants |
Incyte Biosciences Japan G.K. |
The Chiba Cancer Center of Institutional Review Board (The first approved IRB is shown) | |
666-2, Nitona-cho, Chuo-ku, Chiba-shi, Chiba, Japan, Chiba | |
+81-43-264-5431 |
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Approval | |
Yes |
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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 |
NCT04796922 | |
ClinicalTrial.gov |
none |