Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-26 @ 1:10 AM
Study NCT ID:
NCT04534634
Status:
UNKNOWN
Last Update Posted:
2020-09-01
First Post:
2020-08-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of IFN-α Combined With CAR-T Cell Therapy in Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL）
Sponsor:
The First Affiliated Hospital of Soochow University
Organization:
Study Overview
Official Title:
An Open-label, Phase 2, Single-Center Study to Assess the Efficacy and Safety of Interferon-α Combined With Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed and Refractory Acute Lymphoblastic Leukemia（R/R-ALL)
Status:
UNKNOWN
Status Verified Date:
2020-08
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of IFN-α combined with CAR-T cell therapy in relapsed and refractory acute lymphoblastic leukemia (R/R ALL).
Detailed Description:
This is a phase 2, single-center study. The patients will receive IFN-α combined with infusion of CAR T-cells in R/R B-ALL patients. The study participation will be 5 years including treatment and follow-up periods.
Study Oversight
Has Oversight DMC:
True
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?: