Is NCT06249191 recruiting in Portland, OR?

Yes, NCT06249191 is currently recruiting participants at its Portland, OR location. This diffuse large b-cell lymphoma clinical trial is actively enrolling qualified participants.

How do I join the diffuse large b-cell lymphoma clinical trial in Portland?

To join this clinical trial in Portland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Portland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Diffuse Large B-Cell Lymphoma Clinical Trial in Portland, OR

About This Diffuse Large B-Cell Lymphoma Study in Portland

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.

Sponsor: OHSU Knight Cancer Institute

Who Can Participate

Inclusion Criteria

For both phases of the study, participant must be 18-75 years of age and have previously untreated high-grade B cell lymphoma (HGBCL) or diffuse large B cell lymphoma (DLBCL), including transformed DLBCL per the World Health Organization (WHO) 2022 classification, and with documented c-Myc rearrangement on fluorescence in situ hybridization (FISH) testing. Eligible types of c-Myc rearrangements will be performed by FISH testing and may include any single MYC rearrangement (single-hit lymphoma \[SHL\]), Double hit (DHL) lymphoma or and triple hit (THL) lymphoma defined by translocations of MYC and BCL2 (DHL) and BCL6 (THL)

Pathology must be verified and confirmed by university pathologists at the enrolling institution and centrally (OHSU) for any biopsies read outside of either institution

Stage II or higher and International Prognostic Index (IPI) score of 2-5

Able to comply with the study protocol and procedures, in the investigator's judgment

At least one bi-dimensionally measurable nodal lesion, defined as ≥ 1.5 cm in its longest dimension, or one bi-dimensionally measurable extranodal lesion, defined as ≥ 1.0 cm in its longest diameter (patients with measurable disease prior to the pre-phase who have disappearance of measurable disease at initiation of study therapy cycle 1 day 1 \[C1D1\] are eligible)

Confirmed availability of archival or freshly collected tumor tissue before study enrollment

Eastern Cooperative Oncology Group Performance Status of 0, 1, or 2

Left ventricular ejection fraction (LVEF) defined by multiple-gated acquisition (MUGA) scan or echocardiogram (ECHO) within the institutional limits of normal

Absolute neutrophil count (ANC) ≥ 1.0 ×10\^9/L unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion

Platelet count ≥ 75 ×10\^9/L (unless inadequate function is due to underlying disease, as established by extensive bone marrow involvement, or is due to hypersplenism secondary to the involvement of the spleen by lymphoma per the investigator) without transfusion

Serum creatinine ≤ upper limit of normal (ULN); or estimated creatinine clearance ≥ 50 mL/min by Cockcroft Gault method or other institutional standard methods, e.g. based on nuclear medicine renal scan

For persons of childbearing potential (PCBP), an agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of \< 1% per year, and confirmed agreement to refrain from donating eggs, during the treatment period and for at least 3 months after the last dose of mosunetuzumab, and 3 months after the last dose of tocilizumab (if applicable), whichever is longer

For participants who can produce sperm and create pregnancy: confirmed agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm

Exclusion Criteria

Pregnant or breast /chestfeeding

Prior treatment for DLBCL. Exceptions:

Course of bendamustine plus rituximab (BR) treatment \> 3 years prior for follicular lymphoma, or any history of rituximab treatment

As a pre-phase therapy, the following are allowed:

Prednisone of ≤ 100 mg for up to a total of 14 days. Prednisone or equivalent corticosteroid must be discontinued by the time of treatment start. These days do NOT have to be consecutive (i.e., can include multiple courses as long as ≤ 14 days)

One cycle of RCHOP (can be dose reduced) or DA R EPOCH or BR or single agent rituximab

Radiation to up to 3 disease sites

For chemotherapy and radiation, a washout of 3 weeks is required (exception: for mediastinal/pericardial radiation, the washout is 4 weeks)

History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products

Contraindication to receive full dose of any of the individual components of EPOCH

Participants with history of confirmed progressive multifocal leukoencephalopathy (PML)

Known or suspected chronic active Epstein Barr virus (CAEBV) infection

Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology) \

Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) deoxyribonucleic acid (DNA) is undetectable at the time of screening. These Participants must be willing to undergo monthly DNA testing and appropriate antiviral therapy as indicated

Acute or chronic hepatitis C virus (HCV) infection. Participants positive for HCV by antibody testing, but negative for HCV by polymerase chain reaction (PCR) are eligible

HIV seropositivity

Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study

Prior solid organ transplantation

Known or suspected history of hemophagocytic lymphohistiocytosis (HLH).

History of autoimmune disease, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. Exceptions:

Participants with a history of autoimmune-related hypothyroidism on a stable dose of thyroid replacement may be eligible.

Participants with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Participants with a history of disease-related immune thrombocytopenic purpura, autoimmune hemolytic anemia, or other stable autoimmune diseases may be eligible after review and approval by the primary investigator (PI)

Systemic immunosuppressive medications (including, but not limited to, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of pre-phase treatment with prednisone up to 100 mg daily for 7 days (or equivalent corticosteroid dose) prior to cycle 1 day 1 (C1D1). Exceptions:

The use of inhaled corticosteroids is permitted.

The use of mineralocorticoids for management of orthostatic hypotension is permitted.

The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted

Known active central nervous system (CNS) involvement of lymphoma

Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, neurodegenerative disease. Exceptions:

Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed.

Participants with a history of epilepsy who have had no seizures in the past 2 years while not receiving any anti-epileptic medications are allowed in the expansion cohorts only

Prior radiotherapy to the mediastinal / pericardial region within 4 weeks

Prior pre-phase chemotherapy and radiation, within 3 weeks is required (Exception noted for mediastinal/pericardial radiation)

Malignancy treated with curative intent unless in documented remission without treatment for 2 years prior to enrollment, or other malignancy that could affect compliance with the protocol or interpretation of results. Exception: Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix are eligible. Adjuvant endocrine therapy for non-metastatic, hormone receptor-positive breast cancer is permitted

Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results or that could increase risk to the Participant, including renal disease that would preclude chemotherapy administration or pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)

Significant pulmonary disease (including obstructive pulmonary disease and history of bronchospasm)

Significant cardiovascular disease, defined as

New York Heart Association \[NYHA\] Class III or IV cardiac disease,

Congestive heart failure,

Myocardial infarction within the previous 6 months,

Unstable arrhythmias, or

Unstable angina

Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 10 days before C1D1

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) \> 2.5 x ULN

Total bilirubin ≥ 1.5 x ULN

International normalization ratio (INR) \> 1.5 x ULN in the absence of therapeutic anticoagulation

Partial prothrombin time (PTT) or adjusted partial prothrombin time (aPTT) \> 1.5 x ULN in the absence of a lupus anticoagulant

Herbal therapies intended as treatment of lymphoma

Medicinal or recreational cannabis products are not permitted while receiving the study intervention.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Portland?

Yes, this clinical trial (NCT06249191) has an active research site in Portland, OR that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Diffuse Large B-Cell Lymphoma Treatment Options in Portland, OR

If you're searching for diffuse large b-cell lymphoma treatment options in Portland, OR, this clinical trial (NCT06249191) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Portland research site is actively enrolling participants for this clinical trial. You'll receive care from experienced diffuse large b-cell lymphoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all diffuse large b-cell lymphoma clinical trials near you to find additional studies recruiting in your area.

Diffuse Large B-Cell Lymphoma Clinical Trial in Portland, OR

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