NCT06108232

Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Follicular Lymphoma
• Tumor

Interventions

Type	Name	Description
DRUG	Obinutuzumab	Given by IV (vein)
DRUG	CC-99282	Given by PO

Timeline

• Start date: 2024-03-15
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-10-30
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study