Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00171249
Status:
COMPLETED
Last Update Posted:
2021-07-22
First Post:
2005-09-12
Brief Title:
An Extension Study to Determine the Safety and Anti-Leukemic Effects of Imatinib Mesylate in Adult Participants With Ph Leukemia
Sponsor:
Novartis Pharmaceuticals
Organization:
Novartis
Study Overview
Official Title:
An Extension to a Phase II Study to Determine the Safety and Anti-Leukemic Effects of STI571 in Adult Patients With Philadelphia Chromosome Positive Leukemia Including Acute Lymphoblastic Leukemia Acute Myeloid Leukemia and Accelerated Phase Chronic Myeloid Leukemia
Status:
COMPLETED
Status Verified Date:
2021-07
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 objectives of Part 1 of the study were
To determine the rate of hematologic response HR lasting 4 weeks in participants with Philadelphia chromosome-positive Ph chronic myeloid leukemia CML in the accelerated phase AP
To evaluate duration of HR overall survival cytogenetic response CyR time to blast crisis in CML participants in the AP improvement of symptomatic parameters tolerability and safety of STI571 treatment
The objective of the extension Part 2 was
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events
To determine the rate of hematologic response HR lasting 4 weeks in participants with Philadelphia chromosome-positive Ph chronic myeloid leukemia CML in the accelerated phase AP
To evaluate duration of HR overall survival cytogenetic response CyR time to blast crisis in CML participants in the AP improvement of symptomatic parameters tolerability and safety of STI571 treatment
The objective of the extension Part 2 was
-To enable participants to have access to study drug and continue study treatment and to decrease data collection to include only overall survival and serious adverse events
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2005-001381-14 | EUDRACT_NUMBER | None | None |