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Clinical Trial 19072

Cancer Type:
Interventions:Axicabtagene Ciloleucel (KTE-C19); cyclophosphamide; cytoxan (cyclophosphamide); fludarabine (Fludarabine phosphate)

Study Type: Treatment
Phase of Study: Phase II
Investigators:

  • Julio Chavez

Overview

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.

Inclusion Criteria

  • Age 18 years or older
  • Histologically proven indolent Non-Hodgkin Lymphoma (iNHL) that is determined to be high risk as defined by one or more of the following criteria: a) Biopsy-proven progression of Grade 1, Grade 2, or Grade 3, a FL, within 24 months of original diagnosis of disease that was subsequently treated with first-line anti-CD20 monoclonal antibody- and cytotoxic agent-containing combination chemoimmunotherapy (e.g., R-CHOP, R-Bendamustine, R-CVP, R-fludarabine); b) Progression of Grade 1, Grade 2, or Grade 3,a follicular lymphoma (FL), or other iNHL (excluding small lymphocytic lymphoma) within 6 months of completion of second or greater line therapy with anti-CD20 monoclonal antibody- and alkylating agent-containing chemoimmunotherapy; Progression of Grade 1, Grade 2, or Grade 3 a FL, or other iNHL at any point following autologous transplantation.
  • Have measurable disease
  • No known presence or history of central nervous system (CNS) involvement by lymphoma
  • If potential participant is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function
  • Females not pregnant or breastfeeding
  • Males and females willing to use birth control from the time of consent through 6 months following CAR T cell infusion.

    • Exclusion Criteria

  • Transformed follicular lymphoma (FL)
  • Small lymphocytic lymphoma
  • Histological Grade 3b FL
  • Will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant.
  • Has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g., mass effect, tumor lysis syndrome, etc.)

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