Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2025-12-25 @ 7:15 PM
Study NCT ID:
NCT06108232
Status:
RECRUITING
Last Update Posted:
2025-12-19
First Post:
2023-10-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL
Detailed Description:
Objectives:
Primary Objectives:
• To determine the efficacy of obinutuzumab in combination with CC-99282 as determined by complete response (CR) rate after six cycles of combination treatment for patients with previously untreated, high tumor burden follicular lymphoma (FL).
Secondary Objectives:
• To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, CR rate at 30 months (CR30), progression-free survival (PFS), overall survival (OS), and evaluation of safety of obinutuzumab and CC-99282 as treatment for previously untreated patients with FL.
Exploratory Objective:
* To determine the biomarkers that correlates with response and mechanisms of resistance to obinutuzumab and CC-99282 in FL.
* To determine the quality of life in patients with FL receiving obinutuzumab and CC-99282
Primary Objectives:
• To determine the efficacy of obinutuzumab in combination with CC-99282 as determined by complete response (CR) rate after six cycles of combination treatment for patients with previously untreated, high tumor burden follicular lymphoma (FL).
Secondary Objectives:
• To determine best overall response rate (ORR), duration of response (DOR), time to next treatment, CR rate at 30 months (CR30), progression-free survival (PFS), overall survival (OS), and evaluation of safety of obinutuzumab and CC-99282 as treatment for previously untreated patients with FL.
Exploratory Objective:
* To determine the biomarkers that correlates with response and mechanisms of resistance to obinutuzumab and CC-99282 in FL.
* To determine the quality of life in patients with FL receiving obinutuzumab and CC-99282
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-09268 | OTHER | NCI-CTRP Clinical Registry | View |