Ignite Creation Date:
2025-12-24 @ 12:12 PM
Ignite Modification Date:
2025-12-27 @ 10:20 PM
Study NCT ID:
NCT01732861
Status:
COMPLETED
Last Update Posted:
2019-12-20
First Post:
2012-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study of CC-292 and Lenalidomide in Subjects With Chronic Lymphocytic Leukemia/ Small Lymphocytic Lymphoma
Sponsor:
Celgene
Organization:
Study Overview
Official Title:
A MULTICENTER, PHASE 1B, OPEN-LABEL STUDY TO DETERMINE THE SAFETY AND ACTIVITY OF CC-292 IN COMBINATION WITH LENALIDOMIDE IN SUBJECTS WITH RELAPSED AND/OR REFRACTORY CHRONIC LYMPHOCYTIC LEUKEMIA / SMALL LYMPHOCYTIC LYMPHOMA
Status:
COMPLETED
Status Verified Date:
2019-12
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:
This is a dose finding study using a 3 + 3 dose escalation and expansion design to determine a Not Tolerated Dose (NTD), Optimal Biological Effect Dose (OBE) and / or Maximum Tolerated Dose (MTD). These data will be used to establish a Recommended Phase 2 Dose (RP2D) for the combination of CC-292 and lenalidomide in subjects with Chronic Lymphocytic Leukemia (CLL).
Detailed Description:
This dose finding study uses a 3 + 3 dose escalation and expansion design to establish the recommended Phase 2 dose. The starting dose is CC-292 375 mg twice daily and Lenalidomide 10 mg once daily. After review of the data for dose limiting toxicities (DLTs), the second dose level will be enrolled. Doses for this second cohort are CC-292 500 mg twice daily and lenalidomide 10 mg once daily. Additional doses of lenalidomide in combination with CC-292 may be evaluated to accurately determine the maximum tolerated dose. Once the maximum tolerated dose and/or optimal biologic effect has been ascertained, an expansion cohort of 24 subjects may be enrolled.
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 |
|---|---|---|---|---|
| 2012-003766-41 | EUDRACT_NUMBER | None | View |