Ignite Creation Date:
2024-05-06 @ 12:54 PM
Last Modification Date:
2024-10-26 @ 1:05 PM
Study NCT ID:
NCT03876769
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-11
First Post:
2018-11-12
Brief Title:
Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
A Phase II Trial of Tisagenlecleucel in First-line High-risk HR Pediatric and Young Adult Patients With B-cell Acute Lymphoblastic Leukemia B-ALL Who Are Minimal Residual Disease MRD Positive at the End of Consolidation EOC Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASSIOPEIA
Brief Summary:
This is a single arm open-label multi-center phase II study to determine the efficacy and safety of tisagenlecleucel in de novo HR pediatric and young adult B-ALL patients who received first-line treatment and are EOC MRD positive The study will have the following sequential phases screening pre-treatment treatment follow-up and survival After tisagenlecleucel infusion patient will have assessments performed more frequently in the first month and then at Day 29 then every 3 months for the first year every 6 months for the second year then yearly until the end of the study Efficacy and safety will be assessed at study visits and as clinically indicated throughout the study The study is expected to end in approximately 8 years after first patient first treatment FPFT A post-study long term follow-up safety will continue under a separate protocol per health authority guidelines
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2017-002116-14 | EUDRACT_NUMBER | None | None |