Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005613
Status:
COMPLETED
Last Update Posted:
2013-06-04
First Post:
2000-05-02
Brief Title:
Peripheral Stem Cell Transplantation in Treating Patients With Non-Hodgkins Lymphoma or Hodgkins Disease
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Prospective Comparative Trial of Allogeneic Versus Autologous Stem Cell Transplantation for High Risk Lymphoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
CBV
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with allogeneic or autologous peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells
PURPOSE Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
PURPOSE Phase II trial to compare the effectiveness of allogeneic stem cell transplantation with that of autologous peripheral stem cell transplantation in treating patients who have non-Hodgkins lymphoma or Hodgkins disease
Detailed Description:
OBJECTIVES I Compare the relapse rate progression free survival and overall survival in patients with high risk non-Hodgkins lymphoma or Hodgkins disease treated with allogeneic vs autologous stem cell transplantation II Compare the toxicities short and long term of these 2 regimens in these patients
OUTLINE Cytoreductive therapy Patients receive 3 courses of salvage chemotherapy eg dexamethasone high dose cytarabine and cisplatin DHAP etoposide methylprednisolone high dose cytarabine and cisplatin ESHAP fludarabine mitoxantrone and dexamethasone FND Harvest Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell PBSC transplantation group Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group Allogeneic OR autologous PBSC are harvested Conditioning regimen Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4 PBSC are infused on day 0 Patients are followed weekly for 3 months then monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study over 4 years
OUTLINE Cytoreductive therapy Patients receive 3 courses of salvage chemotherapy eg dexamethasone high dose cytarabine and cisplatin DHAP etoposide methylprednisolone high dose cytarabine and cisplatin ESHAP fludarabine mitoxantrone and dexamethasone FND Harvest Patients with an HLA identical sibling donor are assigned to the allogeneic peripheral blood stem cell PBSC transplantation group Patients without an HLA identical sibling are assigned to the autologous PBSC transplantation group Allogeneic OR autologous PBSC are harvested Conditioning regimen Patients receive high dose chemotherapy comprised of cyclophosphamide IV over 1 hour on days -6 to -3 and carmustine IV over 3 hours and etoposide IV over 3 hours on days -6 to -4 PBSC are infused on day 0 Patients are followed weekly for 3 months then monthly for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 120 patients will be accrued for this study over 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-G00-1746 | OTHER | National Cancer Institute | None |
| MCC-11306 | OTHER | None | None |
| IRB-4250 | OTHER | None | None |