OncRef

Clinical Trial: NCT04002401

Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma

Status:

COMPLETED

Phase:

Phase 2

Lead Sponsor:Kite, A Gilead Company
Information Provided By:Gilead Sciences
Last Update Posted:2024-02-20

Study Overview

Brief Summary

The primary objective of this study is to estimate the efficacy of axicabtagene ciloleucel in combination with rituximab, as measured by assessment of response rates in adult participants with relapsed/refractory large B-cell lymphoma.

Official Title

A Phase 2 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of Axicabtagene Ciloleucel in Combination With Rituximab in Participants With Refractory Large B-Cell Lymphoma (ZUMA-14)

Conditions

Refractory Large B-cell Lymphoma

Intervention / Treatment

  • Biological: Axicabtagene Ciloleucel
  • Drug: Rituximab
  • Drug: Fludarabine
  • Drug: Cyclophosphamide

Other Study ID Numbers

  • KT-US-471-0114
  • 2019-004803-11
  • 2019

Start Date (Actual)

2019-11-05

Primary Completion Date (Actual)

2023-01-30

Study Completion Date (Actual)

2023-01-30

Enrollment (Actual)

27

Study Type

Interventional

Phase

Phase 2