Ignite Creation Date:
2024-07-17 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06482684
Status:
RECRUITING
Last Update Posted:
2024-07-01
First Post:
2024-06-26
Brief Title:
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
Sponsor:
Christian Schmidt MD
Organization:
Ludwig-Maximilians - University of Munich
Study Overview
Official Title:
Early Treatment Intensification in Patients With High Risk Mantle Cell Lymphoma Using CAR-T-cell Treatment After an Abbreviated Induction Therapy With Rituximab and Ibrutinib and 6 Months Ibrutinib Maintenance Arm A as Compared to Standard of Care Induction and Maintenance Arm B
Status:
RECRUITING
Status Verified Date:
2024-06
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:
CARMAN
Brief Summary:
First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL
Detailed Description:
This phase II clinical trial will compare the efficacy safety and tolerability of first-line treatment with KTE-X19 after a shortened induction with Rituximab and Ibrutinib to conventional immunochemotherapy and Ibrutinib followed by ASCT in younger patients in high-risk MCL patients or immunochemotherapy plus BTKi for elderly but still fit patients need to be CAR-T-cell eligible As primarily the potential of CAR-T-cell treatment is evaluated within this trial in case of failure to achieve a partial response will be treated with 2 additional cycles of R-CHOP which can be omitted in case of sufficient response to Ibrutinib-based treatment
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-502405-15-01 | CTIS | None | None |