Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245115
Status:
TERMINATED
Last Update Posted:
2018-08-23
First Post:
2005-10-25
Brief Title:
Ex Vivo Expansion of Mafosfamide Purged CD34 Cells in Patients With Acute Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Ex Vivo Expansion of Mafosfamide Purged CD34 Cells in Patients With Acute Leukemia
Status:
TERMINATED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Expiration of study supply
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving colony-stimulating factors such as G-CSF and certain chemotherapy drugs helps stem cells move from the bone marrow to the blood so they can be collected Treating stem cells collected from the patients blood or bone marrow with chemotherapy in the laboratory removes any remaining cancer cells Chemotherapy or radiation therapy is given to the patient to prepare the bone marrow for stem cell transplant The treated stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy
PURPOSE This clinical trial is studying how well an autologous peripheral stem cell or bone marrow transplant using laboratory-treated cells works in treating patients with acute leukemia
PURPOSE This clinical trial is studying how well an autologous peripheral stem cell or bone marrow transplant using laboratory-treated cells works in treating patients with acute leukemia
Detailed Description:
OBJECTIVES
Determine the feasibility of ex vivo expanded mafosfamide-purged CD34-positive cells for autologous peripheral blood stem cell or bone marrow transplantation in patients with acute leukemia
Determine the duration of aplasia associated with the use of ex vivo cytokine expanded mafosfamide-purged cells in patients treated with this regimen
Determine preliminarily the event-free survival of patients treated with this regimen
OUTLINE This is a pilot study
Mobilization and stem cell collection Patients receive cyclophosphamide IV and filgrastim G-CSF subcutaneously SC or IV once daily for 7-14 days followed by leukapheresis to collect peripheral blood stem cells PBSCs Some patients may also undergo bone marrow BM harvest if sufficient PBSCs are not collected Patients with a sufficient number of stem cells or BM 5 x 106 PBSCkg or 3 x 108 BM cellskg proceed to autologous PBSC transplantation PBSCT or BM transplantation BMT
CD34-positive cell selection and mafosfamide purging Collected PBSCs andor BM are treated in the laboratory to isolate CD34-positive cells A minimum of 1 x 106 nucleated CD34-positive BM cellskg or 2 x 106 nucleated CD34-positive PBSCskg must be available after selection to proceed to mafosfamide-purging The selected cells are then treated in vitro with mafosfamide to purge remaining leukemic cells One third of the mafosfamide-purged cells are then cryopreserved for future use and 23 of the mafosfamide-purged cells proceed to ex vivo expansion
Ex vivo expansion The remaining CD34-positive mafosfamide-purged cells are treated in vitro with stem cell factor G-CSF and recombinant human thrombopoietin and incubated for 12-14 days
Myeloablative therapy Patients receive busulfan on days -9 to -6 and cyclophosphamide on days -5 to -2
PBSCT or BMT Patients undergo autologous PBSCT or BMT using CD34-positive mafosfamide-purged cryopreserved cells and ex vivo expanded CD34-positive mafosfamide-purged cells on day 0 followed by G-CSF SC or IV once daily until blood counts recover
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
Determine the feasibility of ex vivo expanded mafosfamide-purged CD34-positive cells for autologous peripheral blood stem cell or bone marrow transplantation in patients with acute leukemia
Determine the duration of aplasia associated with the use of ex vivo cytokine expanded mafosfamide-purged cells in patients treated with this regimen
Determine preliminarily the event-free survival of patients treated with this regimen
OUTLINE This is a pilot study
Mobilization and stem cell collection Patients receive cyclophosphamide IV and filgrastim G-CSF subcutaneously SC or IV once daily for 7-14 days followed by leukapheresis to collect peripheral blood stem cells PBSCs Some patients may also undergo bone marrow BM harvest if sufficient PBSCs are not collected Patients with a sufficient number of stem cells or BM 5 x 106 PBSCkg or 3 x 108 BM cellskg proceed to autologous PBSC transplantation PBSCT or BM transplantation BMT
CD34-positive cell selection and mafosfamide purging Collected PBSCs andor BM are treated in the laboratory to isolate CD34-positive cells A minimum of 1 x 106 nucleated CD34-positive BM cellskg or 2 x 106 nucleated CD34-positive PBSCskg must be available after selection to proceed to mafosfamide-purging The selected cells are then treated in vitro with mafosfamide to purge remaining leukemic cells One third of the mafosfamide-purged cells are then cryopreserved for future use and 23 of the mafosfamide-purged cells proceed to ex vivo expansion
Ex vivo expansion The remaining CD34-positive mafosfamide-purged cells are treated in vitro with stem cell factor G-CSF and recombinant human thrombopoietin and incubated for 12-14 days
Myeloablative therapy Patients receive busulfan on days -9 to -6 and cyclophosphamide on days -5 to -2
PBSCT or BMT Patients undergo autologous PBSCT or BMT using CD34-positive mafosfamide-purged cryopreserved cells and ex vivo expanded CD34-positive mafosfamide-purged cells on day 0 followed by G-CSF SC or IV once daily until blood counts recover
After completion of study treatment patients are followed periodically for at least 5 years
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA006973 | NIH | None | httpsreporternihgovquickSearchP30CA006973 |
| P01CA070970 | NIH | None | None |