Ignite Creation Date:
2025-12-26 @ 5:22 PM
Ignite Modification Date:
2026-03-03 @ 5:18 PM
Study NCT ID:
NCT01933906
Status:
COMPLETED
Last Update Posted:
2019-01-04
First Post:
2013-08-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response
Sponsor:
Arbeitsgemeinschaft medikamentoese Tumortherapie
Organization:
Study Overview
Official Title:
Phase 1 Study to Evaluate the Feasibility and Efficacy of the Addition of P1101 (PEG-Proline-Interferon Alpha-2b) to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complete Molecular Response (MR 4.5 or BCR-ABL Transcripts Not Detectable)
Status:
COMPLETED
Status Verified Date:
2019-01
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:
In this phase I pilot study, it is planned to investigate the feasibility and safety of adding an interferon therapy to an preexisting imatinib treatment in patients with chronic phase chronic myeloid leukaemia. The participating patients have already reached a response during their imatinib therapy (CCyR) but have still a detectable disease (no molecular response MR 4.5 or better).
Detailed Description:
None
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 |
|---|---|---|---|---|
| 2013-000115-24 | EUDRACT_NUMBER | None | View |