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.
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
Interventions
| Drug | Synonyms | Arms |
|---|
| tisagenlecleucel | | CTL019 |
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
| Name | Type | Description | Interventions |
|---|
| CTL019 | Experimental | tisagenlecleucel infusion | |
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: | Active, not recruiting |
| Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- Refractory or relapsed Follicular Lymphoma
- Refractory
- Relapsed
- Follicular lymphoma
- CTL019
- Tisagenlecleucel
- Chimeric antigen receptor
Last Updated
April 6, 2021
