NCT02228096

Study of Efficacy and Safety of CTL019 in Pediatric ALL Patients

A Phase II, Single Arm, Multicenter Trial to Determine the Efficacy and Safety of CTL019 in Pediatric Patients With Relapsed and Refractory B-cell Acute Lymphoblastic Leukemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 3 Years – 21 Years
• Healthy volunteers: Not accepted

Summary

This was a single arm, open-label, multi-center, phase II study to determine the efficacy and safety of an experimental therapy called CTL019 T-cells in pediatric patients with B-cell acute lymphoblastic leukemia, who were refractory to standard chemotherapy regimen or relapsed after allogeneic stem cell transplant.

Conditions

• B-cell Acute Lymphoblastic Leukemia
• Relapsed B-cell Acute Lymphoblastic Leukemia
• Refractory B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	CTL019 T-cells	A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10\^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10\^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10\^8 CTL019 transduced viable T cells (for patients \> 50 kg).

Timeline

• Start date: 2014-08-14
• Primary completion: 2018-05-29
• Completion: 2019-05-24
• First posted: 2014-08-28
• Last updated: 2020-11-23
• Results posted: 2020-11-23

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study