Clinical trial for Ann Arbor Stage II Follicular Lymphoma
Official title Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
ClinicalTrials.gov ID: NCT06442475
What this study is testing
What is Mosunetuzumab?
This is an investigational medicine being studied as a potential treatment for slow-growing follicular lymphoma. It is designed to help the body's immune cells recognize and attack cancer cells.
Also referred to as Lunsumio.
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 study aims to find out if the drug is safe and how well it works in treating this type of cancer.
- Who it's for
- The study is looking for adults with slow-growing B-cell lymphoma, such as follicular or marginal zone lymphoma.
- What's involved
- Participants will receive mosunetuzumab, a type of antibody that may stop cancer cells from growing, and undergo regular medical checks.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 2: a mid-size study of how well it works
- 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
- 18 years or older at time of signing informed consent
- Capable of understanding and providing written informed consent
- Follicular lymphoma (grade 1-2 or 3A)
- Marginal zone lymphoma
- Ann Arbor stage II-IV disease
You likely can't join if
- History of severe allergic reaction to monoclonal antibody therapy
- History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the...
- Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
- Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
- Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if...
- Autoimmune disease requiring active therapy
See the full eligibility criteria
- 18 years or older at time of signing informed consent
- Capable of understanding and providing written informed consent
- Follicular lymphoma (grade 1-2 or 3A)
- Marginal zone lymphoma
- Ann Arbor stage II-IV disease
- No prior therapy for lymphoma
- Nodal or extranodal tumor mass \< 7 cm
- Involvement of less than 3 nodal sites with a diameter \> 3 cm
- No systemic or B symptoms
- No splenomegaly \> 16 cm by imaging
- No local risk of vital organ compression
- No pleural or peritoneal serous effusions
- No leukemic phase (\> 5,0000/ uL circulating lymphocytes)
- No significant cytopenias defined as platelets \< 100,000/uL, hemoglobin \< 10 g/dL, or absolute neutrophil count (ANC) \< 1500/ uL
- Have measurable nodal disease, including at least 1 disease site measuring at least 1.5 cm in longest dimension on CT or fludeoxyglucose F-18 (FDG)-PET, or a FDG-avid extranodal measurable site measuring at least 1.0 cm...
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
- Creatinine clearance ≥ 50 mL/min calculated by Cockcroft-Gault equation
- Total bilirubin ≤ 1.5 x the upper limit of normal (ULN), except in patients with Gilbert's syndrome who may have a total bilirubin up to ≤ 3 x ULN
- Aspartate aminotransferase (AST) ≤ 3 x the ULN
- Alanine aminotransferase (ALT) ≤ 3 x the ULN
- Gamma glutamyl transferase (GGT) ≤ 3 x the ULN
- Negative serum or urine pregnancy test within 7 days of initiating mosunetuzumab for women of childbearing potential, defined as those who have not been surgically sterilized or who have not been free of menses for at...
- Fertile male and woman of childbearing potential must agree to use highly effective contraceptive methods from start of treatment to at least 3 months after the last dose of mosunetuzumab
- History of severe allergic reaction to monoclonal antibody therapy
- History of a second primary malignancy that could affect compliance with the protocol or interpretation of results except with permission of the principal investigator.
- Known active and uncontrolled bacterial, viral, fungal, mycobacterial, or other infection at study enrollment
- Infection with human immunodeficiency virus (unless viral load is undetectable and CD4 count ≥ 200)
- Patients 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...
- Autoimmune disease requiring active therapy
- History of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)
- Evidence of significant concurrent disease or medical condition that could interfere with the conduct of the study, or put the patient at significant risk including, but not limited to, significant cardiovascular...
- Ongoing systemic corticosteroid treatment, with the exception of corticosteroid use for other (non-tumor and non-immunosuppressive) indications up to a maximum of 10 mg/day of prednisone or equivalent
- Prior use of any monoclonal antibody within 4 weeks before the first mosunetuzumab administration
- Prior solid organ transplantation
- Pregnant or breast-feeding women, or intending to become pregnant during the study or within 3 months of the last dose of mosunetuzumab
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Seattle, Washington, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.