Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-02-25 @ 11:48 PM
Study NCT ID:
NCT04156659
Status:
WITHDRAWN
Last Update Posted:
2023-03-09
First Post:
2019-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL
Sponsor:
Novartis Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase II, Single Arm, Multi-center Trial to Evaluate the Efficacy and Safety of Tisagenlecleucel in Chinese Pediatric and Young Adult Patients With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
Status:
WITHDRAWN
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This study was cancelled before enrolling any patients for business related reasons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a single arm, multi-center, phase II study to evaluate the efficacy and safety of tisagenlecleucel in Chinese pediatric and young adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
Detailed Description:
The study will have the following sequential phases for all subjects:
* Screening
* Pre-Treatment (Cell Product Preparation and Lymphodepleting Chemotherapy)
* Treatment and Follow-up Tisagenlecleucel infusion should occur within 16 weeks of informed consent. The total duration of the study is 5 years. After tisagenlecluecel infusion, efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years and semi-annually afterwards up to 5 years, or until the subject relapses.
* Screening
* Pre-Treatment (Cell Product Preparation and Lymphodepleting Chemotherapy)
* Treatment and Follow-up Tisagenlecleucel infusion should occur within 16 weeks of informed consent. The total duration of the study is 5 years. After tisagenlecluecel infusion, efficacy will be assessed monthly for the first 6 months, then quarterly up to 2 years and semi-annually afterwards up to 5 years, or until the subject relapses.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: