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New treatment option for Aggressive Non-Hodgkin Lymphoma
Official title Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma
ClinicalTrials.gov ID: NCT04231877
What this study is testing
What is Polatuzumab Vedotin?
Polatuzumab Vedotin is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for aggressive non-hodgkin lymphoma.
Also referred to as 1313206-42-6, ADC DCDS4501A.
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 phase I trial studies the side effects of polatuzumab vedotin when given with combination chemotherapy with or without glofitamab for the treatment of patients with untreated large B-cell lymphoma that grows and spreads quickly and has severe symptoms (aggressive). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin.
- Phase 1: an early, usually small safety study
- Time commitment: about 5 years
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
- Untreated aggressive B-cell large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to...
- High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
- High grade B-cell lymphoma, not otherwise specified (NOS)
- Diffuse large B-cell lymphoma (DLBCL) NOS
- Primary mediastinal B-cell lymphoma
You likely can't join if
- Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of...
- Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a...
- Richter's transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma is not allowed. Transformation from follicular or other...
- Diagnosis of Burkitt lymphoma
- Prior organ transplantation
- Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
See the full eligibility criteria
Who can join
- Untreated aggressive B-cell large-B cell lymphoma (non-Hodgkin lymphoma) with adverse features that may predict sub-optimal response to rituximab-cyclophosphamide, doxorubicin (hydroxydaunorubicin), vincristine...
- High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
- High grade B-cell lymphoma, not otherwise specified (NOS)
- Diffuse large B-cell lymphoma (DLBCL) NOS
- Primary mediastinal B-cell lymphoma
- T-cell/histiocyte-rich large-B-cell lymphoma
- Epstein-Barr virus (EBV) + DLBCL, NOS
- ALK+ large B-cell lymphoma (must be CD20+)
- B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
- Be willing and able to provide written informed consent for the trial
- Be \>= 18 years of age on day of signing informed consent
- Have measurable disease, including at least 1 nodal site measuring 1.5 cm or 1 extranodal site measuring 1.0 cm in longest dimension on computed tomography (CT) or fluorodeoxyglucose-positron emission tomography...
- Have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale (PS)
- Left ventricular ejection fraction (LVEF) \>= 50% on cardiac multiple-gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)
- Absolute neutrophil count (ANC) \>= 1,000/uL except in cases of marrow infiltration by lymphoma
- Platelets \>= 75,000 / mcL except in cases of marrow infiltration by lymphoma or hypersplenism
- Hemoglobin \>= 8 g/dL except in cases of marrow infiltration by lymphoma without red blood cell (RBC) transfusion within 14 days of first treatment
- Measured or calculated creatinine clearance (Glomerular filtration rate [GFR] can also be used in place of creatinine or creatinine clearance [CrCl]) \>= 40 mL/min. \ Creatinine clearance should be calculated per...
- Serum total bilirubin =\< 1.5 X upper limit of normal (ULN) (Patients with documented Gilbert disease may be enrolled if total bilirubin =\< 3.0 x ULN)
- Direct bilirubin =\ 1.5 ULN
- Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =\< 2.5 X ULN OR =\< 5 X ULN for people with liver...
- International Normalized Ratio (INR) or Prothrombin Time (PT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended...
- Activated partial thromboplastin time (aPTT) =\< 1.5 X ULN unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants, or subject is shown to...
- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of =\< 1% per year during the treatment period and...
- For women of childbearing potential, a negative serum pregnancy test result during screening period. Women who are considered not to be of childbearing potential are not required to have a pregnancy test
- For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm, as defined below: With female partners of childbearing potential or pregnant...
- ARM B ONLY: Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment
What rules you out
- Contraindication to any of the individual components of glofitamab, tocilizumab or EPCH-R, including prior receipt of anthracyclines, or history of severe allergic or anaphylactic reactions to humanized or murine...
- Prior systemic treatment for lymphoma with the exception of corticosteroids. Prior radiotherapy is allowed provided that this site is not used as a measurable site to assess response.
- Richter's transformation from chronic lymphocytic leukemia/small lymphocytic lymphoma is not allowed. Transformation from follicular or other indolent lymphomas is allowed provided that the subject has not received...
- Diagnosis of Burkitt lymphoma
- Prior organ transplantation
- Current Grade \> 1 peripheral neuropathy by clinical examination or demyelinating form of Charcot-Marie-Tooth disease
- Prior systemic therapy for indolent lymphoma
- Prior use of any monoclonal antibody within 3 months of the start of cycle 1; any investigational therapy within 28 days prior to the start of cycle 1; vaccination with live vaccines within 28 days prior the start of...
- Prior therapy for large B-cell lymphoma except for patients who require lymphoma symptom control during screening may receive steroids in the following manner: Up to 30 mg/day of prednisone or equivalent may be used for...
- History of other malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator. The following are eligible without a specific waiver:
- Patients with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible
- Patients with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for \>= 2 years prior to enrollment are eligible
- Patients with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible
- Evidence of significant, uncontrolled, concomitant diseases that could affect compliance with the protocol or interpretation of results, including significant cardiovascular disease (such as New York Heart Association...
- Recent major surgery (within 4 weeks prior to the start of cycle 1), other than for diagnosis
- History or presence of an abnormal electrocardiogram (ECG) that is clinically significant in the investigator's opinion, including complete left bundle branch block, second- or third-degree heart block, or evidence of...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) which requires systemic treatment. Patients may proceed with screening during treatment for...
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology): \ Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B...
- Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) \ Patients positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid...
- History of uncontrolled human immunodeficiency virus (HIV) \ Patients with known diagnosis of HIV must have undetectable viral load, have a CD4 count ≥ 200/μL, and be on anti-retroviral therapy. HIV positive patients...
- Patients with a history of progressive multifocal leukoencephalopathy
- Pregnancy or lactation or intending to become pregnant during study
- ARM B ONLY: Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
- ARM B ONLY: Known or suspected chronic active Epstein-Barr virus infection
- ARM B ONLY: Current or past history of Waldenström macroglobulinemia
- ARM B ONLY: Current or past history of central nervous system (CNS) disease, such as stroke, epilepsy, CNS vasculitis, CNS lymphoma or neurodegenerative disease
- ARM B ONLY: Active autoimmune disease which is not well controlled by therapy
- ARM B ONLY: Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid-replacement hormone may be eligible
- ARM B ONLY: Participants with controlled type 1 diabetes mellitus who are on an insulin regimen are eligible for the study
- ARM B ONLY: Participants with active autoimmune disease with dermatologic manifestations are eligible for the study
- ARM B ONLY: Participants with a history of autoimmune hepatitis, systemic lupus erythematosus, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren...
- ARM B ONLY: Participants with a history of immune thrombocytopenic purpura, autoimmune hemolytic anemia, Guillain-Barré syndrome, myasthenia gravis, myositis, rheumatoid arthritis, vasculitis, or other autoimmune...
- ARM B ONLY: Clinically significant liver disease, including active viral or other hepatitis, current alcohol abuse, or cirrhosis
- ARM B ONLY: Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
- ARM B ONLY: Grade 3 infection within 4 weeks of treatment initiation
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, 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 study runs about 5 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you 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 Seattle, Washington, United States. 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.