Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003960
Status:
COMPLETED
Last Update Posted:
2014-05-02
First Post:
1999-11-01
Brief Title:
Donor Bone Marrow Transplantation in Treating Patients With Hematologic Cancer
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Matched Unrelated and Haploidentical Bone Marrow Transplantation for Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2014-05
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus donor bone marrow transplantation in treating patients who have hematologic cancer
Detailed Description:
OBJECTIVES I Determine the 1-year survival rate of patients with hematologic malignancies after treatment with HLA-matched allogeneic bone marrow transplantation after high-dose chemotherapy
OUTLINE Patients receive oral busulfan four times a day on days -8 to -5 cyclophosphamide IV over 1 hour on days -4 to -1 and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0 CD34 stem cell augmented donor bone marrow is infused on day 0 Methylprednisolone is administered IV over 1 hour on days 5-16 and then tapered Patients are followed every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 3 years
OUTLINE Patients receive oral busulfan four times a day on days -8 to -5 cyclophosphamide IV over 1 hour on days -4 to -1 and methylprednisolone IV over 1 hour every 12 hours on days -2 to 0 CD34 stem cell augmented donor bone marrow is infused on day 0 Methylprednisolone is administered IV over 1 hour on days 5-16 and then tapered Patients are followed every 6 months for 1 year and then annually thereafter
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 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 |
|---|---|---|---|
| NCI-G99-1543 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-98032006 | None | None | None |
| JHOC-J9828 | None | None | None |