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
Overview
- Phase
- Phase 2
- Intervention
- tisagenlecleucel
- Conditions
- Follicular Lymphoma
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 98
- Locations
- 11
- Primary Endpoint
- Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
- Status
- Completed
- Last Updated
- 6 months ago
Overview
Brief Summary
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
Detailed Description
This single-arm, open label study had the following sequential phases: Screening, Pretreatment, Treatment and Follow-up. In the Pre-treatment phase, the patient could undergo bridging therapy (optional) and lymphodepleting (LD) chemotherapy. Treatment and Follow-up Phase included tisagenlecleucel infusion, and safety and efficacy follow-up for at least 24 months. For all the patients who received tisagenlecleucel infusion, additional survival follow-up was to be performed to determine survival status every 3 months.
Investigators
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
- •Other protocol-defined Inclusion/Exclusion criteria may apply.
Arms & Interventions
CTL019
All patients who received tisagenlecleucel infusion.
Intervention: tisagenlecleucel
Outcomes
Primary Outcomes
Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment
Time Frame: 1 year
Complete response rate was defined as the percentage of participants with a best overall response (BOR) of complete response (CR) recorded from tisagenlecleucel infusion until progressive disease or start of new anticancer therapy, whichever came first. CRR was determined by an independent review committee (IRC) and was based on Lugano 2014 classification response criteria. The radiological response is first obtained from CT and PET studies according to the Lugano 2014 criteria. CT response is based on anatomical measurements of index/non-index/new lesions and spleen length. The possible response outcomes are complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD). PET response based on a 5-point scale (5PS) or Deauville score. The possible outcomes for PET response are complete metabolic response (CMR), partial metabolic response (PMR), no metabolic response (NMR), or progressive metabolic disease (PMD).
Secondary Outcomes
- Humoral Immunogenicity(2 years)
- AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- Overall Response Rate (ORR) Per IRC Assessment(1 year)
- Tisagenlecleucel Transgene Concentration(2 years)
- Tmax; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- T1/2; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire(2 years)
- Tlast; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- Progression Free Survival (PFS)(2 years)
- Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire(2 years)
- Duration of Response (DOR) Per IRC(1 year)
- Overall Survival (OS)(2 years)
- Cmax; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel(2 years)
- Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood(2 years)
- Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire(2 years)
- Cellular Immunogenicity(2 years)