OncoMatch/Clinical Trials/NCT04231877
Polatuzumab Vedotin and Combination Chemotherapy With or Without Glofitamab for the Treatment of Untreated Aggressive Large B-cell Lymphoma
Is NCT04231877 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for aggressive non-hodgkin lymphoma.
Treatment: Polatuzumab Vedotin · Rituximab · Prednisone · Etoposide · Doxorubicin · Cyclophosphamide · Glofitamab — 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. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Glofitamab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Drugs used in combination chemotherapy such as etoposide, cyclophosphamide, and doxorubicin work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Giving polatuzumab vedotin in combination chemotherapy with or without glofitamab may help treat patients with aggressive large B-cell lymphoma.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Diffuse Large B-Cell Lymphoma
Biomarker criteria
Required: MYC translocation
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
Required: BCL2 translocation
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
Required: BCL6 translocation
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 translocations
Required: ALK translocation
ALK+ large B-cell lymphoma (must be CD20+)
Required: CD20 expression (positive)
ALK+ large B-cell lymphoma (must be CD20+)
Required: EBV positive
Epstein-Barr virus (EBV) + DLBCL, NOS
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: systemic therapy
Exception: corticosteroids allowed; prior radiotherapy allowed if not used as measurable site
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.
Cannot have received: anthracycline
prior receipt of anthracyclines
Cannot have received: monoclonal antibody
Exception: allowed if >3 months prior to cycle 1
Prior use of any monoclonal antibody within 3 months of the start of cycle 1
Cannot have received: investigational therapy
Exception: allowed if >28 days prior to cycle 1
any investigational therapy within 28 days prior to the start of cycle 1
Lab requirements
Blood counts
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 RBC transfusion within 14 days of first treatment
Kidney function
Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance [CrCl]) ≥ 40 mL/min
Liver function
Serum total bilirubin ≤ 1.5 X ULN (≤ 3.0 x ULN if Gilbert disease); Direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement
Cardiac function
Left ventricular ejection fraction (LVEF) ≥ 50% on cardiac MUGA scan or ECHO
LVEF ≥ 50% on cardiac MUGA scan or ECHO; 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 RBC transfusion within 14 days of first treatment; Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or creatinine clearance [CrCl]) ≥ 40 mL/min; Serum total bilirubin ≤ 1.5 X ULN (≤ 3.0 x ULN if Gilbert disease); Direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 ULN; AST and ALT ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver involvement
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Fred Hutch/University of Washington Cancer Consortium · Seattle, Washington
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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