Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00265889
Status:
COMPLETED
Last Update Posted:
2013-11-20
First Post:
2005-12-14
Brief Title:
Autologous Stem Cell Transplant in Treating Patients With Progressive or Recurrent Hodgkins Lymphoma
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Tandem Autologous Stem Cell Transplantation for Patients With Primary Progressive or Poor Risk Recurrent Hodgkins Disease
Status:
COMPLETED
Status Verified Date:
2013-10
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 Giving two autologous stem cell transplants one after the other may be an effective treatment for Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkins lymphoma
PURPOSE This phase II trial is studying how well giving two autologous stem cell transplants works in treating patients with progressive or recurrent Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Primary
Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkins lymphoma treated with tandem autologous stem cell transplantation 2 courses of high-dose therapy with autologous stem cell rescue
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study Patients are stratified according to risk poor risk primary progressive recurrent or resistant relapse vs good risk first recurrence
Salvage therapy for patients with relapsed disease after achieving a previous complete response Patients receive at least 2 courses of salvage chemotherapy or radiotherapy
Autologous hematopoietic stem cell collection Patients undergo autologous hematopoietic stem cell collection Patients with an inadequate number of collected stem cells are removed from the study
First preparative regimen Patients receive high-dose melphalan IV continuously over 16 hours on day -1
First autologous stem cell transplantation SCT Patients undergo autologous SCT on day 0 They also receive filgrastim G-CSF IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover At least 4-8 weeks later patients proceed to second preparative regimen
Second preparative regimen Patients receive high-dose carmustine IV over 1-2 hours on days -6 -5 and -4 etoposide IV over 4 hours on day -3 and cyclophosphamide IV over 2 hours on day -2 Beginning 36-48 hours later patients proceed to the second autologous SCT day 0
Second autologous SCT Patients undergo second autologous SCT on day 0 Patients also receive filgrastim G-CSF IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
Primary
Determine the 3-year progression-free survival of patients with progressive or recurrent Hodgkins lymphoma treated with tandem autologous stem cell transplantation 2 courses of high-dose therapy with autologous stem cell rescue
Determine the response rate in patients treated with this regimen
Determine the toxic effects of this regimen in these patients
OUTLINE This is a pilot study Patients are stratified according to risk poor risk primary progressive recurrent or resistant relapse vs good risk first recurrence
Salvage therapy for patients with relapsed disease after achieving a previous complete response Patients receive at least 2 courses of salvage chemotherapy or radiotherapy
Autologous hematopoietic stem cell collection Patients undergo autologous hematopoietic stem cell collection Patients with an inadequate number of collected stem cells are removed from the study
First preparative regimen Patients receive high-dose melphalan IV continuously over 16 hours on day -1
First autologous stem cell transplantation SCT Patients undergo autologous SCT on day 0 They also receive filgrastim G-CSF IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover At least 4-8 weeks later patients proceed to second preparative regimen
Second preparative regimen Patients receive high-dose carmustine IV over 1-2 hours on days -6 -5 and -4 etoposide IV over 4 hours on day -3 and cyclophosphamide IV over 2 hours on day -2 Beginning 36-48 hours later patients proceed to the second autologous SCT day 0
Second autologous SCT Patients undergo second autologous SCT on day 0 Patients also receive filgrastim G-CSF IV over 30 minutes once daily beginning on day 5 and continuing until blood counts recover
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 34 patients will be accrued for this study
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 |
| CCF-5386 | OTHER | Cleveland Clinic IRB | httpsreporternihgovquickSearchP30CA043703 |