Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004232
Status:
COMPLETED
Last Update Posted:
2012-06-01
First Post:
2000-01-28
Brief Title:
Bone Marrow and Peripheral Stem Cell Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Augmenting Bone Marrow With CD34 Enriched Peripheral Blood Hematopoietic Stem Cells for Allogeneic Transplantation of Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2012-05
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 Bone marrow and peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells
PURPOSE Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer
PURPOSE Phase I trial to study the effectiveness of bone marrow and peripheral stem cell transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES
Determine the toxicity of unmanipulated bone marrow augmented with CD34 enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation
Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment infection severity of graft-vs-host disease relapse rate and cost effectiveness in this patient population
OUTLINE Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim G-CSF-mobilized CD34 enriched peripheral blood stem cells on day 0
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65 Patients also receive G-CSF subcutaneously daily until blood counts recover
Patients are followed weekly for 3 months at 6 months and 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 30-60 patients will be accrued for this study
Determine the toxicity of unmanipulated bone marrow augmented with CD34 enriched peripheral blood stem cells in patients with hematologic malignancies undergoing allogeneic transplantation
Evaluate this treatment regimen in terms of kinetics of hematopoietic engraftment infection severity of graft-vs-host disease relapse rate and cost effectiveness in this patient population
OUTLINE Patients undergo allogeneic transplantation comprising unmanipulated bone marrow with filgrastim G-CSF-mobilized CD34 enriched peripheral blood stem cells on day 0
Patients receive graft-vs-host disease prophylaxis comprising cyclosporine IV over 24 hours on day -1 and methylprednisolone IV or oral prednisone daily on days 7-65 Patients also receive G-CSF subcutaneously daily until blood counts recover
Patients are followed weekly for 3 months at 6 months and 1 year and then annually for 5 years
PROJECTED ACCRUAL A total of 30-60 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 |
|---|---|---|---|
| NCI-G99-1660 | None | None | None |
| NU-96H4 | None | None | None |