Actively Recruiting
Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)
Led by University Health Network, Toronto · Updated on 2026-04-24
40
Participants Needed
3
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).
CONDITIONS
Official Title
Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women 18 years of age or older eligible for full-dose Pola-R-CHP and possible glofitamab treatment
- Histologic diagnosis of DLBCL or specific variants according to WHO classification
- Previously untreated DLBCL except prior palliative radiotherapy or short corticosteroid use
- ECOG performance status of 0, 1, or 2
- At least one measurable nodal mass (≥1.5 cm) or extranodal mass (≥1.0 cm)
- Left ventricular ejection fraction (LVEF) ≥ 50%
- Women of childbearing potential and men must agree to use highly effective contraception during and after treatment
- Willing and able to participate in required evaluations and procedures
- Ability to understand and sign informed consent
You will not qualify if you...
- Current or past central nervous system lymphoma
- Prior treatment with anthracycline, rituximab, or CD3-targeted bispecific antibody
- Prior malignancy requiring active treatment except certain treated cancers or disease-free for ≥ 2 years
- Significant cardiovascular disease including advanced heart failure, recent myocardial infarction, or unstable arrhythmias
- Significant uncontrolled diseases such as diabetes, pulmonary disorders, or autoimmune diseases
- History of hemophagocytic lymphohistiocytosis (HLH)
- History of drug or alcohol abuse within 12 months
- Active infections or reactivation of latent infections requiring recent treatment
- Known hypersensitivity to study drugs or related proteins
- Current CNS diseases such as recent stroke or neurodegenerative disorders
- Active autoimmune diseases not well controlled by therapy with some exceptions
- Major surgery within 4 weeks before first study dose
- Recent live attenuated vaccine use before treatment
- Use of prohibited therapies including investigational agents, certain biologics, radiotherapy, chemotherapy (except Pola-R-CHP), or chronic steroids
- Positive hepatitis B surface antigen or uncontrolled hepatitis C infection
- Severe blood count abnormalities unless due to lymphoma involvement
- Elevated liver enzymes or impaired kidney function beyond set limits
- Abnormal blood clotting tests without anticoagulants
- Pregnancy or breastfeeding
- Participation in another therapeutic clinical trial
- Other diseases or conditions that contraindicate study drug use
- Peripheral neuropathy grade >1 or demyelinating Charcot Marie Tooth disease
- History of progressive multifocal leukoencephalopathy
- Positive SARS-CoV-2 test within 7 days before enrollment
- Known or suspected chronic active Epstein-Barr viral infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Not Yet Recruiting
2
Princess Margaret Cancer Centre
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
3
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
Research Team
J
John Kuruvilla, FRCPC
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here