Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005948
Status:
COMPLETED
Last Update Posted:
2010-04-02
First Post:
2000-07-05
Brief Title:
Chemotherapy Followed by Peripheral Stem Cell Transplantation And Biological Therapy in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Fred Hutchinson Cancer Center
Organization:
Fred Hutchinson Cancer Center
Study Overview
Official Title:
A Pilot Study of High Dose Busulfan Combined With IL2GM-CSF Activated AutologousSyngeneic PBSC Sequential IL2GM-CSF Therapy and Alpha Interferon Maintenance Therapy as Treatment of CML
Status:
COMPLETED
Status Verified Date:
2010-03
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 Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation and biological therapy in treating patients who have chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of chemotherapy followed by peripheral stem cell transplantation and biological therapy in treating patients who have chronic myelogenous leukemia
Detailed Description:
OBJECTIVES I Determine the toxicity of high-dose busulfan followed by interleukin-2 IL-2 and sargramostim GM-CSF activated autologoussyngeneic peripheral blood stem cell PBSC transplantation sequential IL-2 and GM-CSF therapy and interferon alfa in patients with chronic myelogenous leukemia II Determine engraftment potential of IL-2GM-CSF activated PBSC followed by sequential IL-2GM-CSF therapy in this patient population III Assess the time to cytogenetic andor morphologic relapse overall event-free survival and overall survival in these patients treated with this regimen
OUTLINE Autologous peripheral blood stem cells PBSC are harvested and activated with interleukin-2 IL-2 and sargramostim GM-CSF on another protocol Patients receive oral busulfan every 6 hours on days -6 to -3 for a total of 16 doses IL-2 and GM-CSF-activated PBSC are reinfused on day 0 Beginning 4 hours after PBSC infusion patients receive IL-2 IV continuously for 5 days followed by 2 days of rest for 4 weeks In addition GM-CSF is administered subcutaneously SC every Monday Wednesday and Friday for 4 weeks Upon hematologic recovery but no earlier than 2 weeks after IL-2 and GM-CSF patients receive interferon alfa SC 3 times weekly until clear evidence of disease progression Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2-3 years
OUTLINE Autologous peripheral blood stem cells PBSC are harvested and activated with interleukin-2 IL-2 and sargramostim GM-CSF on another protocol Patients receive oral busulfan every 6 hours on days -6 to -3 for a total of 16 doses IL-2 and GM-CSF-activated PBSC are reinfused on day 0 Beginning 4 hours after PBSC infusion patients receive IL-2 IV continuously for 5 days followed by 2 days of rest for 4 weeks In addition GM-CSF is administered subcutaneously SC every Monday Wednesday and Friday for 4 weeks Upon hematologic recovery but no earlier than 2 weeks after IL-2 and GM-CSF patients receive interferon alfa SC 3 times weekly until clear evidence of disease progression Patients are followed every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study within 2-3 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 |
|---|---|---|---|
| CDR0000067877 | REGISTRY | PDQ | None |
| FHCRC-145500 | None | None | None |
| NCI-G00-1792 | None | None | None |