Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2025-12-31 @ 2:58 PM
Study NCT ID:
NCT01110850
Status:
COMPLETED
Last Update Posted:
2021-03-02
First Post:
2009-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia (CLL) Using Deuterated Water
Sponsor:
Northwell Health
Organization:
Study Overview
Official Title:
Direct Measurement of Leukemic Cell Turnover (Synthesis and Removal) in Patients With Chronic Lymphocytic Leukemia Using Deuterated Water (GAC 0004)
Status:
COMPLETED
Status Verified Date:
2021-03
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:
Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the Western Hemisphere, accounting for \~25% of all leukemia's. It represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B cells. Because of the low proliferative index and a presumed uniform proliferative rate of B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a disease of accumulation rather than proliferation.
Detailed Description:
Chronic lymphocytic leukemia. B-cell chronic lymphocytic leukemia (B-CLL) is the most prevalent leukemia in the Western Hemisphere, accounting for \~25% of all leukemia's. It represents a monoclonal expansion of small, long-lived, apparently slowly dividing CD5+ B cells. Because of the low proliferative index and a presumed uniform proliferative rate of B-CLL cells in vivo (a fact not yet tested or documented), B-CLL appears to be primarily a disease of accumulation rather than proliferation.
B-CLL remains an incurable illness and there is no survival benefit to early intervention.
Therefore, patients with early stage disease are usually followed closely without initiating treatment. Patients with more extensive disease or progressive cytopenias are eventually treated with cytotoxic agents, with or without prednisone, or with nucleoside analogues that promote apoptosis in the leukemic cells. The clinical outcome of the disease is determined both by the profound dysregulation of the immune system that results in infection and autoimmunity and by leukemic infiltration and destruction of organs. Autoimmune phenomena are common and frequently directed against hematopoietic cells, resulting in autoimmune hemolytic anemia (10-25%) or immune thrombocytopenia.
B-CLL remains an incurable illness and there is no survival benefit to early intervention.
Therefore, patients with early stage disease are usually followed closely without initiating treatment. Patients with more extensive disease or progressive cytopenias are eventually treated with cytotoxic agents, with or without prednisone, or with nucleoside analogues that promote apoptosis in the leukemic cells. The clinical outcome of the disease is determined both by the profound dysregulation of the immune system that results in infection and autoimmunity and by leukemic infiltration and destruction of organs. Autoimmune phenomena are common and frequently directed against hematopoietic cells, resulting in autoimmune hemolytic anemia (10-25%) or immune thrombocytopenia.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| GAC # 0004 | OTHER | GAC # 0004 | View |