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New treatment option for Diffuse Large B Cell Lymphoma (DLBCL)
Official title Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL (GRAIL)
ClinicalTrials.gov ID: NCT06050694
What this study is testing
What is glofitamab?
glofitamab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for diffuse large b cell lymphoma (dlbcl).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Men and women ≥ 18 years of age deemed eligible for treatment with full-dose Pola- R-CHP and possible treatment with glofitamab by the qualified...
- Histologic diagnosis of DLBCL and variants according to the WHO 201613 or WHO 202254 classification including DLBCL non-organ-specific (NOS)...
- Previously untreated DLBCL with the following exceptions: (a) prior radiotherapy for palliation (not localized), (b) up to 7 days of corticosteroids...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A...
You likely can't join if
- Current/past history of central nervous system (CNS) lymphoma.
- Prior exposure to any anthracycline, rituximab or cluster of differentiation 3 (CD3) targeted bispecific antibody.
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ...
- Significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or...
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including...
- Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
See the full eligibility criteria
Who can join
- Men and women ≥ 18 years of age deemed eligible for treatment with full-dose Pola- R-CHP and possible treatment with glofitamab by the qualified investigator.
- Histologic diagnosis of DLBCL and variants according to the WHO 201613 or WHO 202254 classification including DLBCL non-organ-specific (NOS), Germinal centre B-cell type, activated B-cell type, T-cell/histiocyte-rich...
- Previously untreated DLBCL with the following exceptions: (a) prior radiotherapy for palliation (not localized), (b) up to 7 days of corticosteroids (prednisone 100mg/day equivalent).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A measurable extranodal mass should have a longest diameter ≥1.0 cm.16
- Left ventricular ejection fraction (LVEF) ≥ 50%, as determined on cardiac multiple- gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 18 months after the last dose of or protocol therapy. Men who are sexually...
- Willing and able to participate in all required evaluations and procedures in this study.
- Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained by the patient or legally acceptable representative before any study-specific procedures are...
What rules you out
- Current/past history of central nervous system (CNS) lymphoma.
- Prior exposure to any anthracycline, rituximab or cluster of differentiation 3 (CD3) targeted bispecific antibody.
- Prior malignancy (or any other malignancy requiring active treatment), except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been...
- Significant or extensive cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 6 months, unstable...
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders (bronchospasm...
- Patients with a known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- History of illicit drug or alcohol abuse within 12 months prior to screening, in the Investigator's judgment.
- Known active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, EBV, cytomegalovirus (CMV), hepatitis B, hepatitis C, and human immunodeficiency virus (HIV)...
- Known history of drug-specific hypersensitivity or anaphylaxis to study drugs (glofitamab and individual components of Pola-R-CHP), including grade III or greater allergic reactions to any monoclonal antibody.
- Known Type I hypersensitivity or anaphylactic reactions to murine proteins, Chinese Hamster Ovary (CHO) cell proteins, or to any component of Rituximab
- Current history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack within the past 2...
- Active autoimmune disease which is not well controlled by therapy:
- Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible. Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are...
- Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.
- Participants with active autoimmune disease with dermatologic manifestations are eligible for the study.
- Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome...
- Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune disease will be...
- Major surgical procedure within 4 weeks of first dose of study drug. Note: If a subject had major surgery, they must have recovered adequately from any toxicity and/or complications from the intervention before the...
- Administration of a live, attenuated vaccine within 4 weeks before study treatment infusion on Cycle 1/Day 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during...
- Use of any of the prohibited therapies including: investigational or unlicensed/unapproved agents; biologic agents (e.g., bevacizumab, erlotinib); immunotherapy/radio-immunotherapy; radiotherapy (with the exception of...
- Positive test results for hepatitis B virus (HBV) infection (defined as positive B surface antigen [HBsAg] serology). Patients with occult or prior HBV infection (defined as negative HBsAg and positive hepatitis B core...
- Positive test results for hepatitis C virus (HCV) antibody. Patients who are positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
- Absolute Neutrophil Count (ANC) \<1.0 x109/L (people with bone marrow involvement by lymphoma are eligible regardless of ANC).
- Hemoglobin (Hgb) ≤ 9 g/dL
- Platelets \<50 x109/L (people with bone marrow involvement by lymphoma are eligible regardless of platelet count)
- Total serum bilirubin \>2 times the upper limit of normal (or \ 3 times the upper limit of normal (or \>5 times for documented hepatic involvement by lymphoma)
- Creatinine clearance \<30 mL/min.
- Prothrombin time (PT)/ international normalized ratio (INR) \>2 times the upper limit of normal in the absence of anticoagulants or partial thromboplastin time (PTT) \>2 times the upper limit of normal in the absence of...
- Breastfeeding or pregnant, or intending to become pregnant during the study or within 12 months after the final dose of Pola-R-CHP, 3 months after the final dose of tocilizumab (if applicable), or 2 months after the...
- Concurrent participation in another therapeutic clinical trial.
- Any other diseases, metabolic dysfunction, physical examination finding, or clinical
- Laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.
- Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot Marie Tooth disease.
- Known history of progressive multifocal leukoencephalopathy.
- Positive severe acute respiratory syndrome (SARS-CoV-2) test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.
- Known or suspected chronic active Epstein-Barr viral infection.
The study team makes the final eligibility decision.
Where it's taking place
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Toronto, Ontario, Canada; Montreal, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.