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New treatment option 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?
Mosunetuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ann arbor stage ii follicular lymphoma.
Also referred to as Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A, BTCT 4465A.
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 II trial tests the safety, side effects and effectiveness of mosunetuzumab in treating patients with slow growing (indolent) B-cell lymphoma. Mosunetuzumab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread.
- 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
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are...
- Follicular lymphoma (grade 1-2 or 3A)
- Marginal zone lymphoma
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)
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbBsAg] serology):
- Patients with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if...
See the full eligibility criteria
- 18 years or older at time of signing informed consent
- Capable of understanding and providing written informed consent
- Histologically confirmed indolent B-cell non-Hodgkin lymphoma with no prior therapy for lymphoma. (Prior peptide-based therapeutic vaccines are allowed.) Eligible histologies include:
- Follicular lymphoma (grade 1-2 or 3A)
- Marginal zone lymphoma
- Ann Arbor stage II-IV disease
- No prior therapy for lymphoma
- Have low-tumor burden disease, defined by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:
- 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. Malignancies treated curatively or at low-risk of...
- 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)
- Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HbBsAg] serology):
- 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's taking place
- 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 - 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?
Study sites include Seattle, Washington, 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.