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New treatment option for Diffuse Large B-Cell Lymphoma
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
ClinicalTrials.gov ID: NCT06249191
What this study is testing
What is Cyclophosphamide?
Cyclophosphamide is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for diffuse large b-cell lymphoma.
Also referred to as (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate.
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 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).
- 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 18 to 75
You may be able to join if
- 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...
- Pathology must be verified and confirmed by university pathologists at the enrolling institution and centrally (OHSU) for any biopsies read outside...
- 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...
You likely can't join if
- 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...
- One cycle of RCHOP (can be dose reduced) or DA R EPOCH or BR or single agent rituximab
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Portland, Oregon, 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, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Portland, Oregon, 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.