Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05800067
Status:
RECRUITING
Last Update Posted:
2023-04-05
First Post:
2022-12-02
Brief Title:
Axi-cel Retreatment in RelapsedRefractory LBCL
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
A Single-arm Prospective Trial of Axicabtagene Ciloleucel Axi-cel Retreatment in RelapsedRefractory Large B-cell Lymphoma
Status:
RECRUITING
Status Verified Date:
2022-08
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:
None
Brief Summary:
This is a prospective single-arm clinical study to explore the efficacy and safety of Axi-cel retreatment in RR LBCL in Shanghai Ruijin Hospital in China
RR LBCL patients who treated with Axi-cel got non-CR or relapsed were eligible for Axi-cel retreatment in this study Patients will receive the standard dose of Axi-cel and follow the standard process Other related treatment like bridging therapy or combination therapy will be based on patients status and investigators decision The primary endpoint is ORR the secondary endpoint is CR PR DOR PFS OS and AE A total of 32 patients is planned to be enrolled in this study The trial will not go on if nobody got CR or PR in first 6 patients
RR LBCL patients who treated with Axi-cel got non-CR or relapsed were eligible for Axi-cel retreatment in this study Patients will receive the standard dose of Axi-cel and follow the standard process Other related treatment like bridging therapy or combination therapy will be based on patients status and investigators decision The primary endpoint is ORR the secondary endpoint is CR PR DOR PFS OS and AE A total of 32 patients is planned to be enrolled in this study The trial will not go on if nobody got CR or PR in first 6 patients
Detailed Description:
This study is a prospective single-arm open-label two-stage study There were 6 cases enrolled in Phase 1 and 26 cases enrolled in Phase 2 for a total of 32 cases
This study aimed to collect data on efficacy and safety after secondary infusion treatment with aquilencel in adult patients with rr LBCL after the first treatment of CD19 CAR-T No form of grouping was performed in this study and subgroup analyses were performed based on the actual data collected
Research Process
The patient has been evaluated for disease after the first treatment of akilencel and the investigator decided to give the patient a second treatment based on clinical practice Obtain informed consent before the second treatment of CD19 CAR-T collect data on the patients disease status before the second dose previous and current decontamination treatment and other related treatments and perform imaging tests such as positron emission tomography and computed tomography PET-CT or electronic computed tomography CT on the same day day 15 day 29 month 3 after secondary administration and 6 9 12 18 and 24 months after secondary administration to confirm the collection of efficacy data and investigators evaluated data on adverse events related to CD19 CAR-T related laboratory results etc
This study aimed to collect data on efficacy and safety after secondary infusion treatment with aquilencel in adult patients with rr LBCL after the first treatment of CD19 CAR-T No form of grouping was performed in this study and subgroup analyses were performed based on the actual data collected
Research Process
The patient has been evaluated for disease after the first treatment of akilencel and the investigator decided to give the patient a second treatment based on clinical practice Obtain informed consent before the second treatment of CD19 CAR-T collect data on the patients disease status before the second dose previous and current decontamination treatment and other related treatments and perform imaging tests such as positron emission tomography and computed tomography PET-CT or electronic computed tomography CT on the same day day 15 day 29 month 3 after secondary administration and 6 9 12 18 and 24 months after secondary administration to confirm the collection of efficacy data and investigators evaluated data on adverse events related to CD19 CAR-T related laboratory results etc
Study Oversight
Has Oversight DMC:
None
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?:
None