Phase 2
Completed N=98
Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
Source: ClinicalTrials.gov NCT03568461 ↗Enrolled (actual)
98
Serious AEs
43.3%
Results posted
Jul 2022
Primary outcomePrimary: Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment — 69.1 Percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response Rate (CRR) Per Independent Review Committee (IRC) Assessment |
69.1 | — |
| SECONDARY Overall Response Rate (ORR) Per IRC Assessment |
86.2 | — |
| SECONDARY Duration of Response (DOR) Per IRC |
— | — |
| SECONDARY Progression Free Survival (PFS) |
— | — |
| SECONDARY Overall Survival (OS) |
— | — |
| SECONDARY Tisagenlecleucel Transgene Concentration |
— | — |
| SECONDARY Cmax; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY Tmax; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY AUC0-28; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY AUC0-84d; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY T1/2; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY Tlast; Cellular Kinetic Parameter of Tisagenlecleucel |
— | — |
| SECONDARY Summary of Exposure of CD3+ Tisagenlecleucel Cells in Peripheral Blood |
— | — |
| SECONDARY Humoral Immunogenicity |
— | — |
| SECONDARY Cellular Immunogenicity |
— | — |
| SECONDARY Summary Scores of PRO Measured by SF-36v2 Quality of Life Questionnaire |
— | — |
| SECONDARY Summary Scores of PRO Measured by EQ-5D-3L Quality of Life Questionnaire |
— | — |
| SECONDARY Summary Scores of PRO Measured by FACT-Lym Quality of Life Questionnaire |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT03568461). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.