Ignite Creation Date:
2024-05-06 @ 11:41 AM
Last Modification Date:
2024-10-26 @ 12:48 PM
Study NCT ID:
NCT03579927
Status:
WITHDRAWN
Last Update Posted:
2020-01-29
First Post:
2018-06-25
Brief Title:
CARCD19-CD28-zeta-2A-iCasp9-IL15-Transduced Cord Blood NK Cells High-Dose Chemotherapy and Stem Cell Transplant in Treating Participants With B-cell Lymphoma
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Immunotherapy With Ex Vivo-Expanded Cord Blood-Derived CAR-NK Cells Combined With High-Dose Chemotherapy and Autologous Stem Cell Transplantation for B-Cell Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of Funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial studies the side effects and best dose of chimeric antigen receptor CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood NK cells when given together with high-dose chemotherapy and stem cell transplant and to see how well they work in treating participants with B-cell lymphoma Cord blood-derived CAR-NK cells may react against the B-cell lymphoma cells in the body which may help to control the disease Giving chemotherapy before a stem cell transplant may help kill any cancer cells that are in the body and helps make room in the patients bone marrow for new blood-forming cells stem cells to grow The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
Detailed Description:
PRIMARY OBJECTIVES
I To establish the safety and relative efficacy of CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood natural killer CB-NK cells in patients with B cell non-Hodgkin lymphoma NHL undergoing high dose chemotherapy and autologous stem cell transplantation
SECONDARY OBJECTIVES
I To estimate the relapse-free survival RFS II To estimate the overall survival OS III To quantify the persistence of infused CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells in the recipient
OUTLINE This is a phase I dose-escalation study of CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells followed by a phase II study
Participants receive rituximab intravenously IV over 3 hours on days -14 and -8 carmustine IV over 2 hours on day -13 etoposide IV over 3 hours twice daily BID on days -12 to -9 cytarabine IV over 1 hour BID on days -12 to -9 melphalan IV over 30 minutes on day -8 CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells IV over 1 hour on day -5 Participants undergo autologous stem cell transplantation ASCT on day 0 Beginning day 0 participants receive filgrastim subcutaneously SC once daily QD until evidence of an absolute neutrophil count ANC of 05 x 109L per 3 consecutive days
After completion of study treatment participants are followed for up to 15 years
I To establish the safety and relative efficacy of CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced cord blood natural killer CB-NK cells in patients with B cell non-Hodgkin lymphoma NHL undergoing high dose chemotherapy and autologous stem cell transplantation
SECONDARY OBJECTIVES
I To estimate the relapse-free survival RFS II To estimate the overall survival OS III To quantify the persistence of infused CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells in the recipient
OUTLINE This is a phase I dose-escalation study of CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells followed by a phase II study
Participants receive rituximab intravenously IV over 3 hours on days -14 and -8 carmustine IV over 2 hours on day -13 etoposide IV over 3 hours twice daily BID on days -12 to -9 cytarabine IV over 1 hour BID on days -12 to -9 melphalan IV over 30 minutes on day -8 CARCD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells IV over 1 hour on day -5 Participants undergo autologous stem cell transplantation ASCT on day 0 Beginning day 0 participants receive filgrastim subcutaneously SC once daily QD until evidence of an absolute neutrophil count ANC of 05 x 109L per 3 consecutive days
After completion of study treatment participants are followed for up to 15 years
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 |
|---|---|---|---|
| NCI-2018-01111 | REGISTRY | None | None |
| 2017-0295 | OTHER | None | None |
| P30CA016672 | NIH | M D Anderson Cancer Center | httpsreporternihgovquickSearchP30CA016672 |