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

Sponsor
University Health Network, Toronto
Study ID
NCT06050694
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • glofitamab — DRUG
    Glofitamab 2.5 mg Cycle 3 Day 8 and 10 mg on Day 15 Cycles 3-6

Study Details

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

Key Dates

Start date
Jan 24, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER

Arms

  • No Intervention: Pola-R-CHP
    Protocol induction: Cycle 1-2 Low-risk group: Cycle 3-4 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, and rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin Cycle 5-6 rituximab 375 mg/m2 on day 1 of cycle 5 and cycle 6
  • Experimental: Pola-R-CHP and glofitamab
    High-risk group: Cycle 3-6 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin and Glofitamab 2.5 mg Cycle 3 Day 8 and 10 mg on Day 15 Cycles 3-6

Primary Outcome Measure

To demonstrate the feasibility of a ctDNA and FDG-PET interim response adapted approach (iRAAp) for the primary therapy of DLBCL [ Time Frame: At the end of cycle 1 (ctDNA) and cycle 2 (PET)(each cycle is 21 days) ]

Central Contacts

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