Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028418
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
2002-01-04
Brief Title:
Clofarabine in Chronic Lymphocytic Leukemia
Sponsor:
MD Anderson Cancer Center
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
Phase I Study of CL-F-ARA-A in Solid and Hematologic Malignancies
Status:
COMPLETED
Status Verified Date:
2001-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a dose-escalation study to determine the maximum tolerated dose and toxic effects of clofarabine in patients with chronic lymphocytic leukemia and other acute leukemias Clofarabine is a synthesized hybrid nucleoside analog which is believed to possess the better qualities of fludarabine and chlorodeoxyadenosine the 2 most active agents against lymphoproliferative disorders Thus it is hoped that this drug will be more active and less toxic than similar drugs
Detailed Description:
The first group of patients will be treated at the starting dose level of 2 mgm2 over 1 hour daily for 5 days Dosage escalation will be permitted in individual patients if no toxicity occurred during the preceding course Subsequent dose escalations will be by 50 until Grade 2 toxicity then by 35 until the maximum tolerated dose
Completion date provided represents the completion date of the grant per OOPD records
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| DM93-036 FD-R-001972-01 | None | None | None |