Viewing Study NCT00003961



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Last Modification Date: 2024-10-26 @ 9:04 AM
Study NCT ID: NCT00003961
Status: COMPLETED
Last Update Posted: 2014-04-17
First Post: 1999-11-01

Brief Title: Sargramostim After Bone Marrow Transplantation in Treating Patients With Myelodysplastic Syndrome
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 GM-CSF After T-Lymphocyte Depleted Allogeneic BMT for Myelodysplastic Syndromes
Status: COMPLETED
Status Verified Date: 2014-04
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 Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood

PURPOSE Phase II trial to study the effectiveness of sargramostim after bone marrow transplantation in treating patients who have myelodysplastic syndrome
Detailed Description: OBJECTIVES

Determine the effect of sargramostim GM-CSF on the progression-free 1-year survival of patients with myelodysplastic syndrome who have undergone T-cell-depleted CD34 augmented allogeneic bone marrow transplantation

OUTLINE All patients receive elutriated CD34 stem cell augmented donor bone marrow according to another protocol on day 0

Patients receive sargramostim GM-CSF subcutaneously on days 5-60

Patients are followed on days 120 180 360 and periodically thereafter

PROJECTED ACCRUAL A total of 45 patients will be accrued for this study within 3-4 years

Study Oversight

Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
Secondary ID Type Domain Link
NCI-G99-1544 US NIH GrantContract None httpsreporternihgovquickSearchP30CA006973
P30CA006973 NIH None None
JHOC-J9852 None None None
JHOC-98071505 None None None