Clinical Trials /

Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma

NCT03568461

Description:

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Related Conditions:
  • Follicular Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CCTL019E2202
  • SECONDARY ID: 2017-004385-94
  • NCT ID: NCT03568461

Conditions

  • Follicular Lymphoma

Interventions

DrugSynonymsArms
tisagenlecleucelCTL019

Purpose

This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.

Trial Arms

NameTypeDescriptionInterventions
CTL019Experimentaltisagenlecleucel infusion
  • tisagenlecleucel

Eligibility Criteria

        Inclusion Criteria:

          -  Refractory or relapsed Follicular Lymphoma (Grade 1, 2, 3A)

          -  Radiographically measurable disease at screening

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Complete response rate (CRR)
Time Frame:2 years
Safety Issue:
Description:CRR based on Lugano classification response criteria

Secondary Outcome Measures

Measure:Overall response rate (ORR)
Time Frame:2 years
Safety Issue:
Description:ORR, including complete response (CR) and partial response (PR)
Measure:Duration of response (DOR)
Time Frame:2 years
Safety Issue:
Description:Time from achievement of CR or PR to relapse or death due to follicular lymphoma
Measure:Progression free survival (PFS)
Time Frame:2 years
Safety Issue:
Description:Time from tisagenlecleucel infusion to first documented disease progression or death due to any cause
Measure:Overall survival (OS)
Time Frame:2 years
Safety Issue:
Description:Time from tisagenlecleucel infusion to death due to any cause
Measure:tisagenlecleucel transgene concentration
Time Frame:2 years
Safety Issue:
Description:Transgene concentration as detected by qPCR in target tissue
Measure:Cmax; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The maximum (peak) observed in peripheral blood or other body fluid drug concentration after single dose administration (% or copies/ µg)
Measure:Tmax; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The time to reach maximum (peak) peripheral blood or other body fluid drug concentration after single dose administration (days)
Measure:AUC0-28; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The AUC from time zero to day 28, in peripheral blood (%*days or days*copies/ µg)
Measure:AUC0-84d; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The AUC from time zero to day 84, in peripheral blood (%*days or days*copies/ µg)
Measure:T1/2; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The half-life associated with the elimination phase slope of a semi logarithmic concentration-time curve (days) in peripheral blood
Measure:Tlast; cellular kinetic parameter of tisagenlecleucel
Time Frame:2 years
Safety Issue:
Description:The last observed measureable timepoint after dose administration
Measure:Summary of exposure of CD3+ tisagenlecleucel cells in peripheral blood
Time Frame:2 years
Safety Issue:
Description:In vivo cellular kinetics of CD3+ tisagenlecleucel cells detected by flow cytometry
Measure:humoral immunogenicity
Time Frame:2 years
Safety Issue:
Description:Antibody titers specific to the tisagenlecleucel molecule prior to and following infusion.
Measure:cellular immunogenicity
Time Frame:2 years
Safety Issue:
Description:Presence of T lymphocytes activated by the tisagenlecleucel protein
Measure:Summary scores of PRO measured by SF-36v2 quality of life questionnaire
Time Frame:2 years
Safety Issue:
Description:Effect of tisagenlecleucel therapy on Patient reported outcomes
Measure:Summary scores of PRO measured by EQ-5D-3L quality of life questionnaire
Time Frame:2 years
Safety Issue:
Description:Effect of tisagenlecleucel therapy on Patient reported outcomes
Measure:Summary scores of PRO measured by FACT-Lym quality of life questionnaire
Time Frame:2 years
Safety Issue:
Description:Effect of tisagenlecleucel therapy on Patient reported outcomes

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Novartis Pharmaceuticals

Trial Keywords

  • Refractory or relapsed Follicular Lymphoma
  • Refractory
  • Relapsed
  • Follicular lymphoma
  • CTL019
  • Tisagenlecleucel
  • Chimeric antigen receptor

Last Updated

December 5, 2019