WHO ICTRP trial
A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib…
JPRN-jRCT2031230073 · Japan Primary Registries Network (JPRN) · Not Recruiting
Key facts
| Trial ID | JPRN-jRCT2031230073 |
|---|---|
| Public title | A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) - The COASTAL Study |
| Scientific title | A Phase 3, Randomized, Open-Label, Controlled, Multicenter Study of Zandelisib (ME-401) in Combination with Rituximab Versus Standard Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin's Lymphoma (iNHL) - The COASTAL Study |
| Primary sponsor | Hanaya Miyoko |
| Secondary sponsors | Kyowa Kirin Co., Ltd. |
| Registry | Japan Primary Registries Network (JPRN) |
| Recruitment status | Not Recruiting |
| Study type | Interventional |
| Phase | 3 |
| Countries | Argentina;Japan;Australia;Japan;Austria;Japan;Belgium;Japan;Canada;Japan;Colombia;Japan;Czech Republic;Japan;France;Japan;Georgia;Japan;Germany;Japan;Greece;Japan;Hungary;Japan;Ireland;Japan;Italy;Jap… |
| Conditions | Follicular Lymphoma, Marginal zone lymphoma |
| Interventions | Subjects who meet the eligibility criteria will be randomly assigned in a 1:1 ratio to one of the treatment arms: - Arm 1: R plus zandelisib - Arm 2: R plus chemotherapy (CHOP or B) Zandelisib: Administered in a 28-day cycle. Zandelisib… |
| Registration date | May 15, 2023 |
| Target size | 534 |
| Secondary IDs | NCT04745832 |
| Registry page | jrct.niph.go.jp |
At a glance
- No Results available
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About WHO ICTRP trial registrations
The WHO ICTRP combines trial registrations from primary registries worldwide into a single searchable index. Contact and ethics-committee details are not shown here.
Source: World Health Organization (WHO), International Clinical Trials Registry Platform (ICTRP) · Source date: