Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006379
Status:
COMPLETED
Last Update Posted:
2011-12-08
First Post:
2000-10-04
Brief Title:
Non-Ablative Allo HSCT For Hematologic Malignancies or SAA
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Purine-Analog-Containing Non-Myeloablative Allogeneic Stem Cell Transplantation for Treatment of Hematologic Malignancies and Severe Aplastic Anemia
Status:
COMPLETED
Status Verified Date:
2011-12
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 cancer cells from dividing so they stop growing or die Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill cancer cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer or aplastic anemia
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have hematologic cancer or aplastic anemia
Detailed Description:
OBJECTIVES
Determine the rates of durable full donor hematologic engraftment in patients with high-risk hematologic malignancies or severe aplastic anemia treated with non-myeloablative conditioning using fludarabine cyclophosphamide and anti-thymocyte globulin followed by allogeneic peripheral blood stem cell transplantation
Determine the acute and delayed toxic effects of this non-myeloablative conditioning regimen in this patient population
Determine the event-free and overall survival of patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the rate and quality of immune reconstitution in patients treated with this regimen
Determine the rate of disease relapse and incidence of post-transplantation lymphoproliferative disease in these patients
OUTLINE Patients are stratified according to disease category malignant vs non-malignant and graft source unrelated vs HLA-matched sibling
Beginning at least 4 weeks after conventional-dose chemotherapy patients receive non-myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -4 cyclophosphamide IV over 2 hours on days -3 to -2 and anti-thymocyte globulin IV over at least 4 hours on days -2 and -1 Patients undergo filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation on day 0
Patients are followed weekly for 3 months every 2 weeks for 3 months monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A minimum of 30 patients will be accrued for this study within 4 years
Determine the rates of durable full donor hematologic engraftment in patients with high-risk hematologic malignancies or severe aplastic anemia treated with non-myeloablative conditioning using fludarabine cyclophosphamide and anti-thymocyte globulin followed by allogeneic peripheral blood stem cell transplantation
Determine the acute and delayed toxic effects of this non-myeloablative conditioning regimen in this patient population
Determine the event-free and overall survival of patients treated with this regimen
Determine the incidence and severity of acute and chronic graft-versus-host disease in patients treated with this regimen
Determine the rate and quality of immune reconstitution in patients treated with this regimen
Determine the rate of disease relapse and incidence of post-transplantation lymphoproliferative disease in these patients
OUTLINE Patients are stratified according to disease category malignant vs non-malignant and graft source unrelated vs HLA-matched sibling
Beginning at least 4 weeks after conventional-dose chemotherapy patients receive non-myeloablative conditioning comprising fludarabine IV over 30 minutes on days -8 to -4 cyclophosphamide IV over 2 hours on days -3 to -2 and anti-thymocyte globulin IV over at least 4 hours on days -2 and -1 Patients undergo filgrastim G-CSF-mobilized allogeneic peripheral blood stem cell transplantation on day 0
Patients are followed weekly for 3 months every 2 weeks for 3 months monthly for 6 months and then every 2 months thereafter
PROJECTED ACCRUAL A minimum of 30 patients will be accrued for this study within 4 years
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 |
|---|---|---|---|
| NCI-G00-1868 | Other Identifier | University Hospitals IRB | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |
| CWRU-3Y00 | OTHER | None | None |
| 05-00-07 | OTHER | None | None |