NCT06050694

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)

Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).

Detailed description

This is a multicenter, phase II, non-randomized, open-label, single-arm study in patients with untreated DLBCL. Patients will be on treatment for a total of 6 cycles, each 21 days in length. After receiving 2 cycles of polatuzumab vedotin, cyclophosphamide, doxorubicin, prednisone (Pola-R-CHP), a risk-adapted approach will be used to modify therapy for patients who are found to be of an unfavourable risk. Pola-R-CHP chemotherapy will be administered every 21 days at standard doses: polatuzumab vedotin 1.8 mg/kg IV on day 1, cyclophosphamide 750 mg/m2 IV on day 1, doxorubicin 50 mg/m2 IV on day 1, prednisone 100 mg orally daily days 1-5, and rituximab 375 mg/m2 IV within 72 hours of polatuzumab vedotin and CHP. No subcutaneous administration of rituximab is allowed in this study. All patients will undergo circulating tumour DNA (ctDNA) evaluation in peripheral blood at baseline and prior to cycle 2 of Pola-R-CHP. Interim response will also be assessed by 18-fluorodeoxyglucose positron emission tomography (FDG-PET) scan response prior to cycle 3 of treatment positron emission tomography (PET2). Based on these tests, patients will be risk stratified into two treatment arms. The ctDNA low-risk patients (favourable ctDNA and PET2) will receive two additional cycles of Pola-R-CHP chemotherapy followed by 2 additional courses of rituximab. See Table 3 for exact treatment dosing for Cycles 3 - 6. The ctDNA high-risk risk group (unfavourable ctDNA and/or PET2) will receive 4 additional cycles of Pola-R-CHP chemotherapy given with glofitamab. See Table 4 for exact treatment dosing for Cycles 3 - 6. Following six cycles of treatment, patients in both groups will undergo treatment assessment with CT scan, PET/CT scan, and bone marrow biopsy (as required). Following completion of protocol treatment, patients will go into survival follow-up. Routine assessments will include patient visits with laboratory testing including ctDNA testing every 3 months. Imaging studies (PET/CT scan) will be repeated every 6 months.

Conditions

• Diffuse Large B Cell Lymphoma (DLBCL)

Interventions

Type	Name	Description
DRUG	glofitamab	Glofitamab 2.5 mg Cycle 3 Day 8 and 10 mg on Day 15 Cycles 3-6

Timeline

• Start date: 2025-01-24
• Primary completion: 2025-11-01
• Completion: 2027-11-01
• First posted: 2023-09-22
• Last updated: 2025-04-06

Locations

2 sites across 1 country: Canada