Actively Recruiting
Feasibility Trial of Glofitamab Using Interim FDG PET and ctDNA to Optimize Primary Therapy of Diffuse Large B Cell Lymphoma
Led by University Health Network, Toronto · Updated on 2026-04-24
40
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for adults with untreated diffuse large B cell lymphoma (DLBCL) in this phase II, multicenter study. The study focuses on using a response-adapted strategy based on interim blood tests measuring circulating tumor DNA (ctDNA) and scans using FDG-PET to optimize therapy. This approach aims to better tailor treatment according to individual risk and tumor response early in the treatment process. Participants will receive six cycles of therapy, each lasting 21 days. The first two cycles include a combination of polatuzumab vedotin, cyclophosphamide, doxorubicin, prednisone, and rituximab (Pola-R-CHP). After these initial cycles, patients are assessed with ctDNA testing and PET scans. Those with favorable risk continue with two more cycles of Pola-R-CHP followed by two cycles of rituximab alone. Patients at higher risk receive four additional cycles of Pola-R-CHP combined with the drug glofitamab. Treatment doses and schedules are carefully monitored and adjusted based on these risk assessments. Throughout the study, participants undergo regular evaluations including blood tests for ctDNA, PET/CT scans, CT scans, and bone marrow biopsies as needed. After completing treatment, patients enter a follow-up phase with visits every three months for lab tests and ctDNA monitoring, and imaging every six months. The main outcome measured is the feasibility of adapting therapy based on interim ctDNA and PET results. Secondary outcomes include survival, treatment side effects, and quality of life over a two-year period. The total involvement in the study spans approximately two years from treatment start through follow-up.
CONDITIONS
Brief 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...
- Adults aged 18 years or older eligible for full-dose Pola-R-CHP and possible glofitamab treatment
- Histologic diagnosis of DLBCL or specified variants per WHO classification
- Previously untreated DLBCL with limited prior corticosteroid or radiotherapy use
- ECOG performance status 0, 1, or 2
- At least one measurable nodal or extranodal mass of specified size
- Left ventricular ejection fraction of 50% or higher
- Women of childbearing potential must use effective contraception during treatment and for 18 months after
- Men must use effective contraception during treatment and for 6 months after
- Willing and able to participate in required study evaluations
- Able to understand and sign informed consent
You will not qualify if you...
- History or current central nervous system lymphoma
- Prior treatment with anthracyclines, rituximab, or CD3-targeted bispecific antibodies
- Recent or active malignancy except certain treated skin or cervical cancers
- Significant cardiovascular disease including recent heart attack or unstable conditions
- Uncontrolled diseases like diabetes or autoimmune disorders
- Known or suspected hemophagocytic lymphohistiocytosis
- Recent substance abuse within 12 months
- Active infections or recent severe infections requiring hospitalization
- Known allergies to study drugs or components
- Current CNS diseases like stroke or epilepsy within 2 years
- Active autoimmune diseases not well controlled by therapy
- Recent major surgery within 4 weeks prior to treatment
- Recent live vaccine use or planned live vaccines during study
- Use of prohibited therapies including certain biologics, immunotherapy, or steroids
- Positive hepatitis B surface antigen or active hepatitis C infection
- Blood count and liver/kidney function outside specified limits
- Pregnant or breastfeeding women or intending pregnancy within specified timeframes
- Participation in another therapeutic clinical trial
- Other diseases or conditions contraindicating study drug use
- Grade greater than 1 peripheral neuropathy or known progressive multifocal leukoencephalopathy
- Positive COVID-19 test within 7 days prior to enrollment
- Known or suspected chronic active Epstein-Barr viral infection
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 weeks (6 cycles of 21 days each)
Participants receive 6 cycles of chemotherapy treatment over approximately 18 weeks. After 2 cycles of polatuzumab vedotin, cyclophosphamide, doxorubicin, prednisone and rituximab (Pola-R-CHP), interim blood tests and PET scans determine risk status to guide further therapy. Low-risk participants receive 2 more cycles of Pola-R-CHP followed by 2 cycles of rituximab. High-risk participants receive 4 additional cycles of Pola-R-CHP combined with glofitamab.
6 visits (in-person, one per treatment cycle)
Duration - Up to 24 months
After completing treatment, participants enter survival follow-up with regular laboratory testing including ctDNA every 3 months and PET/CT scans every 6 months to monitor health and disease status.
Quarterly visits with laboratory testing and imaging every 6 months
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
OTHER
Number of Arms
2
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