Trial Title:
Low Dose Mosunetuzumab for the Treatment of Patients With Indolent B-Cell Lymphoma
NCT ID:
NCT06442475
Condition:
Ann Arbor Stage II Follicular Lymphoma
Ann Arbor Stage II Marginal Zone Lymphoma
Ann Arbor Stage III Follicular Lymphoma
Ann Arbor Stage III Marginal Zone Lymphoma
Ann Arbor Stage IV Follicular Lymphoma
Ann Arbor Stage IV Marginal Zone Lymphoma
Grade 1 Follicular Lymphoma
Grade 2 Follicular Lymphoma
Grade 3a Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Lymphoma, B-Cell, Marginal Zone
Antibodies, Bispecific
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood, oral, and/or rectal sample collection
Arm group label:
Treatment (mosunetuzumab)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT or CT
Arm group label:
Treatment (mosunetuzumab)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Treatment (mosunetuzumab)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Biological
Intervention name:
Mosunetuzumab
Description:
Given IV
Arm group label:
Treatment (mosunetuzumab)
Other name:
Anti-CD20 x Anti-CD3 Bispecific Monoclonal Antibody BTCT4465A
Other name:
BTCT 4465A
Other name:
BTCT-4465A
Other name:
BTCT4465A
Other name:
CD20/CD3 BiMAb BTCT4465A
Other name:
Lunsumio
Other name:
Mosunetuzumab-axgb
Other name:
RG 7828
Other name:
RG-7828
Other name:
RG7828
Other name:
RO7030816
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Treatment (mosunetuzumab)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Treatment (mosunetuzumab)
Summary:
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.
Detailed description:
OUTLINE:
Patients receive mosunetuzumab intravenously (IV) over 2-4 hours on days 1, 8, 15 and 22.
Patients also undergo blood sample collection and positron emission tomography
(PET)/computed tomography (CT) on study. Patients may undergo CT and/or magnetic
resonance imaging (MRI) as clinically indicated and may undergo collection of oral and/or
rectal swabs on study.
After completion of study treatment, patients are followed up at week 13, at 6 months,
and then for up to 5 years per institutional standards.
Criteria for eligibility:
Criteria:
Inclusion 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 in longest dimension.
Measurable disease also includes spleen size more than 13 cm in vertical length
- 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 least 1 year
- 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
Exclusion Criteria:
- 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 progressing at the
judgment of the principal investigator (PI) may be included
- 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 time of
screening. These patients must be willing to undergo monthly DNA testing and
appropriate antiviral therapy as indicated by institutional standards
- 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 disease (e.g., New York Heart Association
class III or IV cardiac disease, unstable arrhythmias, or unstable angina) or
pulmonary disease (including obstructive pulmonary disease and history of
bronchospasm)
- 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Ajay Gopal
Phone:
206-606-2037
Email:
agopal@uw.edu
Investigator:
Last name:
Ajay Gopal
Email:
Principal Investigator
Start date:
August 29, 2024
Completion date:
February 12, 2027
Lead sponsor:
Agency:
University of Washington
Agency class:
Other
Source:
University of Washington
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06442475
