Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 5:51 AM
Study NCT ID:
NCT00406757
Status:
COMPLETED
Last Update Posted:
2017-11-13
First Post:
2006-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Nelarabine (506U78)in Japanese Patients With Leukemia or Lymphoma
Sponsor:
GlaxoSmithKline
Organization:
Study Overview
Official Title:
Clinical Evaluation of 506U78 in Japanese Patients With Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia or T-cell Lymphoblastic Lymphoma.
Status:
COMPLETED
Status Verified Date:
2017-11
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:
In Japan, patients with relapsed or refractory T-ALL/T-LBL represent an extremely small patient population. While the small number of patients presents a practical limitation to the size of a clinical trial, patients whose disease has not responded to or has relapsed after treatment with multiple prior chemotherapy regimens have no accepted standard therapies available. Japanese leukemia experts have expressed interest in evaluating 506U78 in Japanese patients with relapsed or refractory T-ALL/T-LBL. In order to obtain safety, tolerability, and pharmacokinetic data of 506U78 in Japanese patients, this study is designed to maximize the contribution of each available patient.
Detailed Description:
None
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?: