Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003116
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
1999-11-01
Brief Title:
High-Dose Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Allogeneic Peripheral Blood Progenitor Cell Transplantation Using Histocompatible Sibling-Matched Donor Cells After High-Dose BusulfanCyclophosphamide as Therapy for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2010-06
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:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE This phase II trial is studying how well giving busulfan cyclophosphamide and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer
PURPOSE This phase II trial is studying how well giving busulfan cyclophosphamide and filgrastim together with peripheral stem cell transplantation from a sibling donor works in treating patients with hematologic cancer
Detailed Description:
OBJECTIVES
Determine the safety and feasibility of using allogeneic peripheral blood progenitor cell infusions obtained from normal histocompatible sibling donors for reconstituting bone marrow and immunologic function when given after high-dose busulfancyclophosphamide in patients with a hematologic malignancy
Determine the efficacy of this treatment in these patients
Determine the ability to mobilize hematopoietic progenitor cells from normal donors given filgrastim G-CSF by determining the hematopoietic progenitor cell content of allogeneic peripheral blood progenitor cell collections
Determine the incidence of engraftment failures in these patients
Determine the incidence of severe acute graft-versus-host disease in these patients
OUTLINE Patients receive high-dose oral busulfan every 6 hours on days -8 to -5 cyclophosphamide IV twice a day on days -4 and -3 and cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses allogeneic only Allogeneic peripheral blood progenitor cells IV are administered on day 0
Filgrastim G-CSF is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover
Patients are followed every month for 2 months every 3 months for 6 months and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued over a 15 month period
Determine the safety and feasibility of using allogeneic peripheral blood progenitor cell infusions obtained from normal histocompatible sibling donors for reconstituting bone marrow and immunologic function when given after high-dose busulfancyclophosphamide in patients with a hematologic malignancy
Determine the efficacy of this treatment in these patients
Determine the ability to mobilize hematopoietic progenitor cells from normal donors given filgrastim G-CSF by determining the hematopoietic progenitor cell content of allogeneic peripheral blood progenitor cell collections
Determine the incidence of engraftment failures in these patients
Determine the incidence of severe acute graft-versus-host disease in these patients
OUTLINE Patients receive high-dose oral busulfan every 6 hours on days -8 to -5 cyclophosphamide IV twice a day on days -4 and -3 and cyclosporine IV over 6 hours on day -1 and then 10 hours on day 0 for 2 doses allogeneic only Allogeneic peripheral blood progenitor cells IV are administered on day 0
Filgrastim G-CSF is administered subcutaneously twice a day beginning 3 hours after completion of cell infusion and continuing until blood counts recover
Patients are followed every month for 2 months every 3 months for 6 months and then every 6 months until disease progression
PROJECTED ACCRUAL A total of 40 patients will be accrued over a 15 month period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| P30CA043703 | NIH | None | None |
| CASE-CWRU-1995 | None | None | None |
| NCI-G97-1354 | None | None | None |
| CASE1995T | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |