Actively Recruiting
Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma
Led by OHSU Knight Cancer Institute · Updated on 2026-04-24
30
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
Sponsors
O
OHSU Knight Cancer Institute
Lead Sponsor
G
Genentech, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This phase Ib/II clinical trial tests the safety, side effects, and effectiveness of mosunetuzumab with chemotherapy for the treatment of patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma. 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). Immunotherapy with monoclonal antibodies, such as mosunetuzumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs, such as etoposide, doxorubicin, vincristine, cyclophosphamide and prednisone work in different ways to stop the growth of cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving mosunetuzumab with chemotherapy may be safe, tolerable and/or effective in treating patients with untreated, c-Myc rearrangement positive, high grade B cell lymphoma or diffuse large B cell lymphoma.
CONDITIONS
Official Title
Mosunetuzumab With Chemotherapy for the Treatment of Patients With Untreated C-Myc Rearrangement Positive High Grade B Cell Lymphoma or Diffuse Large B Cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 75 years
- Previously untreated high-grade B cell lymphoma or diffuse large B cell lymphoma including transformed DLBCL with documented c-Myc rearrangement by FISH testing
- Pathology confirmed by university and central pathologists
- Stage II or higher disease with International Prognostic Index score of 2 to 5
- Able to comply with study protocol and procedures
- At least one measurable nodal lesion (≥1.5 cm) or extranodal lesion (≥1.0 cm)
- Availability of archival or fresh tumor tissue before enrollment
- Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2
- Left ventricular ejection fraction within normal institutional limits
- Adequate blood counts and hemoglobin without transfusion as specified
- Serum creatinine within normal limits or creatinine clearance ≥50 mL/min
- For persons of childbearing potential, agreement to use effective contraception or remain abstinent during treatment and specified periods after last dose
- For participants who can produce sperm, agreement to use condom or remain abstinent and not donate sperm
You will not qualify if you...
- Pregnant or breastfeeding
- Prior treatment for DLBCL except limited prednisone or one cycle of RCHOP or DA R EPOCH
- History of severe allergic reactions to monoclonal antibodies or murine products
- Contraindication to full dose of any EPOCH components
- History of progressive multifocal leukoencephalopathy
- Known or suspected chronic active Epstein Barr virus infection
- Positive for chronic hepatitis B infection (exceptions with monitoring)
- Acute or chronic hepatitis C infection
- HIV positive
- Recent live attenuated vaccine within 4 weeks before treatment
- Prior solid organ transplantation
- History of hemophagocytic lymphohistiocytosis
- History of autoimmune diseases with some exceptions
- Use of systemic immunosuppressive medications except specified corticosteroids
- Active central nervous system lymphoma or recent CNS disease
- Prior mediastinal/pericardial radiotherapy within 4 weeks
- Recent other malignancies except certain treated skin or cervical cancers
- Significant uncontrolled diseases affecting compliance or risk
- Significant pulmonary or cardiovascular disease as defined
- Active infection requiring IV antibiotics or hospitalization within 4 weeks
- Significant liver disease or abnormal liver function tests as specified
- Use of herbal therapies for lymphoma
- Use of medicinal or recreational cannabis during study treatment
AI-Screening
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Trial Site Locations
Total: 1 location
1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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