Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002778
Status:
TERMINATED
Last Update Posted:
2011-07-20
First Post:
1999-11-01
Brief Title:
Sargramostim Following Allogeneic Bone Marrow Transplantation in Treating Patients With Chronic Myelogenous Leukemia
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
GRANULOCYTE-MACROPHAGE COLONY STIMULATING FACTOR Rhu-GM-CSF FOR REDUCTION OF LEUKEMIC RELAPSE AFTER T-LYMPHOCYTE DEPLETED ALLOGENEIC BMT FOR CHRONIC MYELOID LEUKEMIA
Status:
TERMINATED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
subject accrual and data analysis is completed
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 work in different ways to stop cancer cells from dividing so they stop growing or die Combining chemotherapy with allogeneic bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more cancer cells Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia
PURPOSE Phase II trial to study the effectiveness of allogeneic bone marrow transplantation followed by sargramostim in treating patients who have chronic myelogenous leukemia
Detailed Description:
OBJECTIVES
Determine whether the use of sargramostim GM-CSF after T-cell depleted CD34-positive cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in patients with chronic myelogenous leukemia
OUTLINE Patients receive myeloablation with busulfan and cyclophosphamide on an approved protocol Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody T-cell depleted CD34-positive cell-supplemented bone marrow is infused on day 0 Patients receive high-dose sargramostim GM-CSF subcutaneously SC beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60
Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation without GM-CSF is considered in case of primary or secondary engraftment failure
Patients are followed every month for 3 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within approximately 6-10 years
Determine whether the use of sargramostim GM-CSF after T-cell depleted CD34-positive cell-supplemented allogeneic bone marrow transplantation can reduce leukemic relapse in patients with chronic myelogenous leukemia
OUTLINE Patients receive myeloablation with busulfan and cyclophosphamide on an approved protocol Allogeneic bone marrow is harvested and treated in vitro with anti-CD34 antibody T-cell depleted CD34-positive cell-supplemented bone marrow is infused on day 0 Patients receive high-dose sargramostim GM-CSF subcutaneously SC beginning on day 5 and continuing until blood counts recover and then low-dose GM-CSF SC continuing until day 60
Donor lymphocyte infusions or second unmodified allogeneic bone marrow transplantation without GM-CSF is considered in case of primary or secondary engraftment failure
Patients are followed every month for 3 months every 3 months for 1 year every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within approximately 6-10 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 |
|---|---|---|---|
| NCI-V96-0900 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P01CA015396 | NIH | None | None |
| P30CA006973 | NIH | None | None |
| JHOC-J9449 | None | None | None |
| BRLX-0010649 | None | None | None |
| JHOC-94110404 | None | None | None |