Ignite Creation Date:
2024-05-05 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 9:38 AM
Study NCT ID:
NCT00573378
Status:
TERMINATED
Last Update Posted:
2023-01-25
First Post:
2007-12-13
Brief Title:
Imatinib or Nilotinib With Pegylated Interferon-α2b in Chronic Myeloid Leukemia
Sponsor:
University of Michigan Rogel Cancer Center
Organization:
University of Michigan Rogel Cancer Center
Study Overview
Official Title:
A Combination of Imatinib or Nilotinib Together With Pegylated Interferon-α2b in Chronic-Phase Chronic Myeloid Leukemia A Phase II Pilot Study Targeting Both the Primitive and Differentiated CML Progenitor Populations
Status:
TERMINATED
Status Verified Date:
2023-01
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:
To investigate whether patients with chronic-phase chronic myeloid leukemia CP-CML who have achieved a complete cytogenetic response CCyR on imatinib IM or nilotinib N can then be treated with a combination of the tyrosine kinase inhibitor TKI and interferon-α2b PEG-IFN-a2b IFN for 2 years subsequently have their therapy discontinued and then maintain a durable molecular response off all therapy Relapse-free survival RFS rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective
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 |
|---|---|---|---|
| HUM9600 | OTHER | University of Michigan Medical IRB | None |