NCT05008055

Study of Capivasertib in Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

A Modular Phase II, Open-Label, Multicentre Study to Assess the Efficacy and Safety of Capivasertib in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma (CAPITAL)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, multicenter Phase II study of capivasertib administered orally in participants with Relapsed or Refractory (R/R) B-cell Non-Hodgkin's Lymphoma (NHL).

Detailed description

The study protocol follows a modular design. The study will investigate the safety and efficacy of capivasertib monotherapy in participants with R/R Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), and Mantle Cell Lymphoma (MCL).

Conditions

• Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Capivasertib	Capivasertib will be taken orally twice a day (BD) 4 days on/ 3 days off.

Timeline

• Start date: 2021-11-03
• Primary completion: 2023-08-22
• Completion: 2024-10-25
• First posted: 2021-08-17
• Last updated: 2024-12-20
• Results posted: 2024-06-20

Locations

17 sites across 7 countries: United States, Canada, Denmark, France, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study