Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004997
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-03-22
Brief Title:
Leucovorin for the Treatment of 5 q Minus Syndrome
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Experimental Treatment of Transfusion Dependent 5q Minus Syndrome With Leucovorin
Status:
COMPLETED
Status Verified Date:
2002-07
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:
The 5 q minus syndrome is a condition that occurs due to a missing segment of chromosome 5 in the normal genetic make-up of the cells responsible for forming blood cells The condition causes patients to have the inability to make blood normally Many patients with this syndrome need transfusions of red blood cells platelets andor white blood cells Low levels of platelets may cause the patient to bleed easily and low levels of whit blood cells make the patient susceptible to infections A small number of patients with 5 q minus syndrome develop leukemia which is often untreatable with chemotherapy
Researchers believe that one of the genes missing in 5 q minus syndrome is the gene responsible for making folic acid active in the body Folic acid is a vitamin required for normal blood production
The purpose of this study to test the effectiveness of a drug called leucovorin for the treatment of 5 q minus syndrome Leucovorin is an active form of the vitamin folic acid that does not require the missing genes to activate it
Patients participating in this study may or may not improve with leucovorin treatment However the study will improve researchers understanding of the disease and may lead other potential therapies for the disease
Researchers believe that one of the genes missing in 5 q minus syndrome is the gene responsible for making folic acid active in the body Folic acid is a vitamin required for normal blood production
The purpose of this study to test the effectiveness of a drug called leucovorin for the treatment of 5 q minus syndrome Leucovorin is an active form of the vitamin folic acid that does not require the missing genes to activate it
Patients participating in this study may or may not improve with leucovorin treatment However the study will improve researchers understanding of the disease and may lead other potential therapies for the disease
Detailed Description:
The objective of this protocol is to determine whether leucovorin treatment can normalize hematopoietic cell growth and differentiation in patients with 5q- syndrome which may lack the gene for dihydrofolate reductase enzyme
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 |
|---|---|---|---|
| 98-CC-0101 | None | None | None |