Efficacy and Safety of Tisagenlecleucel in Adult Patients With Refractory or Relapsed Follicular Lymphoma
- Interventional
- Active
- NCT03568461
Contact Information
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
This is a multi-center, phase II study to determine the efficacy and safety of tisagenlecleucel in adult patients with relapsed or refractory FL.
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.
Gender
All
Age Group
18 Years and up
Accepting Healthy Volunteers?
No
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.
- 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.