Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005984
Status:
TERMINATED
Last Update Posted:
2017-11-29
First Post:
2000-07-05
Brief Title:
Cyclophosphamide and Filgrastim Followed By SCT in Patients With Chronic or Accelerated Phase Myelogenous Leukemia
Sponsor:
Masonic Cancer Center University of Minnesota
Organization:
Masonic Cancer Center University of Minnesota
Study Overview
Official Title:
Autologous Marrow Transplantation for Chronic Myelogenous Leukemia Using Stem Cells Obtained After In Vivo CyclophosphamideG-CSF Priming
Status:
TERMINATED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study terminated as principal investigator PI left the university
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Giving colony-stimulating factors such as G-CSF and cyclophosphamide helps stem cells move from the patients bone marrow to the blood so they can be collected and stored Chemotherapy and radiation therapy is then given to prepare the bone marrow for the stem cell transplant The stem cells are returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy and radiation therapy
PURPOSE This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia
PURPOSE This phase II trial is studying how well cyclophosphamide plus filgrastim followed by stem cell transplant works in treating patients with chronic phase or accelerated phase chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Assess the clinical outcomes survival and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim G-CSF followed by autologous peripheral blood stem cell transplantation
Determine whether priming with cyclophosphamide and filgrastim G-CSF increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells PBSC and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients
OUTLINE Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim G-CSF daily subcutaneously SQ starting on day 5 and continuing until completion of leukapheresis Peripheral blood stem cells PBSC are collected between days 14-21
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1 Patients receive the PBSC transplantation on day 0 Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression
Patients are followed at 3 weeks then at 3 6 9 12 and 18 months and then annually for 5 years
PROJECTED ACCRUAL Not specified
Assess the clinical outcomes survival and morbidity of patients with chronic or accelerated phase chronic myelogenous leukemia when treated with cyclophosphamide and filgrastim G-CSF followed by autologous peripheral blood stem cell transplantation
Determine whether priming with cyclophosphamide and filgrastim G-CSF increases the fraction of benign Philadelphia chromosome negative hematopoietic progenitors in peripheral blood stem cells PBSC and reduces the incidence of persistent or recurrent leukemia after autologous transplantation with mobilized PBSC in these patients
OUTLINE Patients receive priming therapy consisting of cyclophosphamide IV over 2 hours on day 1 and filgrastim G-CSF daily subcutaneously SQ starting on day 5 and continuing until completion of leukapheresis Peripheral blood stem cells PBSC are collected between days 14-21
Patients then receive preparative therapy for transplant consisting of cyclophosphamide IV over 2 hours on days -7 and -6 and total body irradiation twice a day on days -4 through -1 Patients receive the PBSC transplantation on day 0 Patients also receive G-CSF IV starting on day 0 and continuing until blood counts recover Patients then receive interferon alfa SQ daily in the absence of unacceptable toxicity or disease progression
Patients are followed at 3 weeks then at 3 6 9 12 and 18 months and then annually for 5 years
PROJECTED ACCRUAL Not specified
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 |
|---|---|---|---|
| UMN-MT-1996-11 | OTHER | Blood and Marrow Transplantation Program | None |