Ignite Creation Date:
2024-05-05 @ 4:37 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00274794
Status:
COMPLETED
Last Update Posted:
2011-03-29
First Post:
2006-01-10
Brief Title:
VP and G-CSF With or Without Rituximab in Autologous Peripheral Stem Cell Transplant For NHL
Sponsor:
The Cleveland Clinic
Organization:
The Cleveland Clinic
Study Overview
Official Title:
A Prospective Randomized Trial of VP-16 Plus G-CSF Plus Rituximab vs VP-16 Plus G-CSF Alone for Peripheral Blood Progenitor Cell Mobilization Prior to Autologous Stem Cell Transplantation for B Cell Lymphoid Malignancies
Status:
COMPLETED
Status Verified Date:
2011-03
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 such as busulfan etoposide and cyclophosphamide work in different ways to stop the growth of cancer cells either by killing the cells or by stopping them from dividing Giving colony-stimulating factors such as G-CSF monoclonal antibodies such as rituximab or chemotherapy such as etoposide helps stem cells move from the bone marrow to the blood so they can be collected and stored until transplant Giving etoposide and G-CSF together with rituximab before a peripheral stem cell transplant may be an effective treatment for non-Hodgkins lymphoma
PURPOSE This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkins lymphoma
PURPOSE This randomized clinical trial is studying how well giving etoposide and G-CSF with or without rituximab works in treating patients who are undergoing an autologous peripheral stem cell transplant for B-cell non-Hodgkins lymphoma
Detailed Description:
OBJECTIVES
Determine whether mobilization with etoposide and filgrastim G-CSF with or without rituximab influences CD34 cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkins lymphoma
Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients
OUTLINE This is a randomized study
Stem cell mobilization Patients are randomized to 1 of 2 mobilization arms
Arm I Patients receive rituximab IV over 4 hours on days 1 8 and 15 Patients also receive etoposide IV over 4 hours on day 15 and filgrastim G-CSF subcutaneously SC beginning on day 17 and continuing until approximately day 25 Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected After stem cell collection is completed patients proceed to the preparative regimen
Arm II Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11 Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected After stem cell collection is completed patients proceed to the preparative regimen
Preparative regimen Patients receive oral busulfan once daily on days -8 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Autologous peripheral blood stem cell transplantation PBSCT Patients undergo autologous PBSCT on day 0 Beginning on day 5 patients receive G-CSF SC or IV once daily until blood counts recover
After completion study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 54 patients will be accrued for this study
Determine whether mobilization with etoposide and filgrastim G-CSF with or without rituximab influences CD34 cell yield in patients undergoing autologous peripheral blood stem cell transplantation for B-cell non-Hodgkins lymphoma
Determine the acute toxicity of rituximab in combination with etoposide and G-CSF for peripheral blood stem cell mobilization in these patients
OUTLINE This is a randomized study
Stem cell mobilization Patients are randomized to 1 of 2 mobilization arms
Arm I Patients receive rituximab IV over 4 hours on days 1 8 and 15 Patients also receive etoposide IV over 4 hours on day 15 and filgrastim G-CSF subcutaneously SC beginning on day 17 and continuing until approximately day 25 Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected After stem cell collection is completed patients proceed to the preparative regimen
Arm II Patients receive etoposide IV over 4 hours on day 1 and G-CSF SC beginning on day 3 and continuing until approximately day 11 Patients then undergo apheresis over 5 days or until an adequate amount of stem cells are collected After stem cell collection is completed patients proceed to the preparative regimen
Preparative regimen Patients receive oral busulfan once daily on days -8 to -4 etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on days -3 and -2
Autologous peripheral blood stem cell transplantation PBSCT Patients undergo autologous PBSCT on day 0 Beginning on day 5 patients receive G-CSF SC or IV once daily until blood counts recover
After completion study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 54 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 |
| CASE-CCF-3600 | None | None | None |
| CASE-CCF-0467 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA043703 |