Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2026-01-11 @ 12:20 AM
Study NCT ID:
NCT02494258
Status:
COMPLETED
Last Update Posted:
2025-05-22
First Post:
2015-07-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate Long-term Safety of CC-486 (Oral Azacitidine) in Subjects With Hematological Disorders
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A Phase 2, Open-Label, Single-Arm Rollover Study to Evaluate Long-Term Safety in Subjects Who Participated in Other Celgene Sponsored CC-486 (Oral Azacitidine) Clinical Trials in Hematological Disorders
Status:
COMPLETED
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03723135
Has Expanded Access, NCT# Status:
APPROVED_FOR_MARKETING
Acronym:
None
Brief Summary:
Rollover study supporting hematological disorder indications from Celgene sponsored CC-486 (oral azacitidine) protocols eligible for participation in the study.
Detailed Description:
The open-label, multicenter, multinational rollover study is intended to evaluate the safety of CC-486 (oral azacitidine), while providing continued treatment with CC-486 for subjects who are receiving single agent CC-486 at the time of transition to the rollover study and tolerated the protocol prescribed regimen in Celgene-sponsored trials, and whom in the opinion of the Investigator may derive clinical benefit from continuing treatment with CC-486. Subjects' survival will also be followed if required by the parent CC-486 study protocol. If approved by Celgene, subjects from any ongoing or future Celgene sponsored CC-486 studies in hematological disorders will be included in this protocol.
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 |
|---|---|---|---|---|
| 2023-503272-25 | EUDRACT_NUMBER | None | View |