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Clinical Trial 19072
Cancer Type: Malignant Hematology
Study Type: Treatment
NCT#: NCT03105336
Phase: Phase II
Prinicipal Investigator: Julio Chavez
Study Title
A Phase 2 Multicenter Study of Axicabtagene Ciloleucel in Subjects with Relapsed/Refractory Indolent Non-Hodgkin Lymphoma (iNHL)
Summary
The main purpose of this research study is to determine if the experimental product, KTE-C19, when administered after participants receive a 3 day course of chemotherapy, is safe and effective in treating their disease.
Objective
The primary objective is to estimate the efficacy of axicabtagene ciloleucel, as measured by objective response rate, in subjects with relapsed or refractory (r/r) indolent non-Hodgkin lymphoma (iNHL). A key secondary endpoint will be progression-free survival (PFS). Additional secondary objectives will include additional safety and efficacy endpoints.
Therapies
Medications
Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide (); cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)
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