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CCTL019E2202 Elara

AcronymISRCTNEudraCTClinicaltrials.govDRKS
2017-004385-94

A Phase II, single arm, multicenter open label trial to determine the efficacy and safety of tisagenlecleucel (CTL019) in adult patients with refractory or relapsed follicular lymphoma

Status: Active (Recruitment Closed)

Purpose / Objectives

Primary Outcome

  • Evaluate the efficacy of tisagenlecleucel therapy as measured by complete
    response rate determined by Independent Review Committee in the full analysis set based on Lugano 2014 classification response criteria

Secondary Outcomes

  • Evaluate the efficacy of tisagenlecleucel as measured by additional efficacy measures, including Overall Response Rate (ORR), Duration of Response (DOR), Progression Free Survival (PFS) and Overall Survival (OS).
  • Evaluate safety of tisagenlecleucel
  • Characterize the in vivo cellular kinetics (levels, expansion, persistence) of tisagenlecleucel transduced cells into target tissues (blood, bone marrow, and other tissues if available) and CD3+ tisagenlecleucel cells in peripheral blood
  • Characterize the incidence and prevalence of tisagenlecleucel immunogenicity (humoral and cellular)
  • Characterize the impact of pre-existing and treatment induced immunogenicity on cellular kinetics, efficacy and safety
  • Describe the effect of tisagenlecleucel therapy on patient reported outcomes

Diagnosis

Patient attributes

Age

18-99

Inclusion criteria

  • FL (Grade 1, 2, 3A) confirmed histologically by central pathology review beforetisagenlecleucel infusion.
  • Sufficient formalin-fixed paraffin-embedded (FFPE) tumor samples obtained for this studywith a corresponding pathology report must be submitted. If not clinically feasible, an archival tumor biopsy from the most recent relapse may be submitted. However, in case of clinical symptoms, abnormal laboratory tests, and radiological images suggesting histologic transformation, a fresh biopsy will be required. Excisional biopsies should be submitted; if not possible, a core needle biopsy is allowed. Fine needle aspiration (FNA) is not allowed.
  • FL meeting one of the following criteria:
    • Refractory to a second line or later line of systemic therapy (including an anti-CD20 antibody and an alkylating agent) or relapsed within 6 months after completion of a second line or later line of systemic therapy
    • Relapsed during anti-CD20 antibody maintenance (following at least two lines of therapies as above) or within 6 months after maintenance completion
    • Relapsed after autologous HSCT

  • Radiographically measurable disease at screening defined as:
    • At least one nodal lesion greater than 20 mm in the long axis, regardless of the length of the short axis AND/OR
    • Extranodal lesions (outside lymph node or nodal mass, including liver and spleen) greater than 10 mm in long AND short axis
  • [...]

Exclusion criteria

  • Evidence of histologic transformation
  • Follicular Lymphoma Grade 3B
  • Prior anti-CD19 therapy
  • Prior gene therapy
  • Prior adoptive T cell therapy
  • Prior allogeneic hematopoietic stem cell transplant
  • Active CNS involvement by malignancy
  • Active neurological autoimmune or inflammatory disorders (e.g. Guillain-Barre syndrome, Amyotrophic Lateral Sclerosis)
  • Presence of active or prior hepatitis B or C as indicated by serology

  • Cardiac or cardiac repolarization abnormalities defined in the protocol

 

Trial design

  • Phase II
  • Multicenter
  • Prospective
  • One-arm
  • Open Label

Documents (password protected)

Responsibilities in overall trial

Novartis Pharma GmbH

  • Tel. 0911 2730
  • Fax 0911 27312683

National Coordinating Investigator

Prof. Dr. med. Martin Dreyling

Study Sites

Klinik I für Innere Medizin

Study office

  • Klinisches Studienzentrum der Klinik I für Innere Medizin Köln

Status

Active (Recruitment Closed)

Principal Investigator

Priv.-Doz. Dr. med. Bastian von Tresckow

Deputy of Principal Investigator

  • Prof. Dr. med. Peter Borchmann
  • PD Dr. Dr. med. Udo Holtick

Subinvestigator

  • PD Dr. med. Boris Böll
  • Dr. med. Anja Lohneis
  • Dr. med. Nadine Kutsch
  • Dr. med. Carmen Diana Herling

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