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New treatment option for Diffuse Large B Cell Lymphoma (DLBCL)
Official title A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT06765317
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, given as an infusion into a vein, 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
- The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 80
You may be able to join if
- Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi)
- Age ≥80 years with any fitness level
- Pathologically confirmed DLBCL, HGBCL or transformed lymphoma
- No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible)
- Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1)
You likely can't join if
- Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)
- Prior solid organ transplantation
- Prior allogeneic stem cell transplantation
- Active CNS involvement
- Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load and previously treated HBV and HCV are allowed) 5.1...
- Uncontrolled active systemic infection
See the full eligibility criteria
Who can join
- Age 65-79 years with a fitness assessment of unfit or frail per simplified GA (Appendix 1, www.filinf.it/epi)
- Age ≥80 years with any fitness level
- Pathologically confirmed DLBCL, HGBCL or transformed lymphoma
- No prior systemic anti-lymphoma therapy (prednisone/equivalent up to 100 mg daily x 7 days is permissible)
- Ann Arbor Stage 2 bulky, 3 or 4 disease (Appendix 1)
- Any IPI score (Appendix 1)
- Anthracycline eligible: LVEF ≥ 45% by echocardiogram or MUGA scan.
- Must have at least one bi-dimensionally measurable lesion (\>1.5 cm in its largest dimension for nodal lesions, or \>1.0 cm in its largest dimension for extranodal lesions by computerized tomography [CT] scan or MRI)
- Eastern Cooperative Oncology Group performance status ≤ 2 (Appendix 1)
- Must have adequate organ and marrow status:
- Absolute neutrophil count (ANC) ≥1,000/mm3 or ≥500/mm3 if due to disease involvement in the bone marrow
- Platelet count ≥50,000 cells/mm3 or ≥25,000/mm3 if due to disease involvement in the bone marrow
- Patients who do not meet criteria for bone marrow function due to marrow involvement of lymphoma and/or other disease-related cytopenias (e.g., immune thrombocytopenia) may be enrolled into the study after discussion...
- Serum creatinine ≤ULN OR estimated Creatinine Clearance (CrCl) ≥30 mL/min (Cockcroft-Gault formula or other institutional standard methods)
- Serum aspartate transaminase (AST) or alanine transaminase (ALT) ≤3 x upper limit of normal (ULN)
- Total bilirubin ≤ 1.5 x ULN (≤3 if due to Gilbert's syndrome or liver involvement by the lymphoma
- Patients who do not meet criteria for liver function due to liver involvement of lymphoma may be enrolled into the study after discussion with, and confirmation by the PI.
- Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided, prior to enrollment, they are stable on antiretroviral therapy, have a CD4 count...
- Signed Informed Consent Form(s)
- Ability to comply with all the study-related procedures, in the investigator's judgement
- Female patients who are not of child bearing potential (i.e., who are postmenopausal or surgically sterile). For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use...
What rules you out
- Prior systemic anti-lymphoma therapy (localized radiation, steroids and antibiotics are permitted)
- Prior solid organ transplantation
- Prior allogeneic stem cell transplantation
- Active CNS involvement
- Uncontrolled HIV or active HBV or HCV infection (controlled HIV with undetectable viral load and previously treated HBV and HCV are allowed) 5.1 Participants with occult or prior hepatitis B infection (defined as...
- Uncontrolled active systemic infection
- Major surgery within 4 weeks of the first dose of study drug (exceptions may be allowed after discussion with PI if patient has fully recovered from procedure and antilymphoma therapy is urgently needed)
- Significant or extensive history of 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 3 months prior to...
- Uncontrolled autoimmune disorder
- A history of confirmed progressive multifocal leukoencephalopathy
- Any life-threatening illness, medical condition, or organ system dysfunction that, in the investigator's opinion, could compromise the subject's safety or risk study outcomes
- Inability to comply with all the study-related procedures, in the investigator's judgement.
- Contraindication to any of the individual components of polatuzumab, R-miniCHP and glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or...
- Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T...
- Prior use of any monoclonal antibody for the purposes of treating cancer within 3 months of the start of Cycle 1
- Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
- Prior radiotherapy to the mediastinal/pericardial region. Radiotherapy to non-target lesion sites will be permitted.
- Corticosteroid use \> 50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control 18.1 Participants receiving corticosteroid treatment with ≤ 50 mg/day of prednisone or equivalent for reasons...
- Participants who require lymphoma symptom control during screening may receive steroids in the following manner: - Up to 100 mg of prednisone PO (or equivalent steroids) per day for up to 7 days are allowed. Prednisone...
- History of other malignancy that could affect compliance with the protocol or interpretation of results: 20.1 Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or...
- Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and...
The study team makes the final eligibility decision.
Where it's taking place
- Basking Ridge, New Jersey, United States
- Hackensack, New Jersey, United States
- Middletown, New Jersey, United States
- Montvale, New Jersey, United States
- Commack, New York, United States
- Harrison, New York, United States
- New York, New York, United States
- Rockville Centre, New York, United States
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, 65 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basking Ridge, New Jersey, United States; Hackensack, New Jersey, United States; Middletown, New Jersey, United States; Montvale, New Jersey, United States; Commack, New York, United States; Harrison, New York, United States and 2 more location(s). 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.