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Compares treatment options for Classic Follicular Lymphoma
Official title Comparing Rituximab and Mosunetuzumab Drug Treatments for People With Low Tumor Burden Follicular Lymphoma
ClinicalTrials.gov ID: NCT06337318
What this study is testing
What is Mosunetuzumab?
Mosunetuzumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for classic 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 III trial compares the effectiveness of rituximab to mosunetuzumab in treating patients with follicular lymphoma with a low tumor burden. Rituximab is a monoclonal antibody.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
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
- Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per...
- NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is...
- Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL)...
- Participants must have low-tumor burden follicular lymphoma defined as:
- Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
See the full eligibility criteria
Who can join
- Participants must have a histologically confirmed diagnosis of classic follicular lymphoma (cFL). cFL was previously categorized as grade 1-3A per World Health Organization (WHO)-HAEM4R, but grading of classic...
- NOTE: Participants with follicular lymphoma with uncommon features (uFL) are eligible, including FL with diffuse growth pattern (dFL). Diagnosis is as per local pathology. Lymphoma fluorescence in situ hybridization...
- Participants must not have follicular lymphoma with "blastoid" or "large centrocyte" cytological features, or follicular large B-cell lymphoma (FLBL) (previously categorized as follicular lymphoma grade 3B)
- Participants must have low-tumor burden follicular lymphoma defined as:
- Nodal or extra-nodal tumor mass with diameter less than 7 cm in its greater diameter
- Involvement of no more than 3 nodal or extra nodal sites with diameter greater than 3 cm.
- Absence of B symptoms which may include unexplained fever, drenching sweats, unintentional weight loss (more than 10% of body weight)
- No symptomatic splenomegaly
- No compression syndrome (ureteral, orbital, gastrointestinal)
- No pleural or peritoneal serous effusion related to follicular lymphoma Participants must have Ann Arbor stage II, III, or IV follicular lymphoma. Participants with stage I disease may be included if they do not wish to...
- Participants must either be experiencing distress due to their disease or would prefer active management of their disease rather than a watch and wait approach
- Participants must have staging imaging performed within 49 days prior to registration, as follows. PET-CT baseline scans are preferred. If a baseline PET-CT scan cannot be obtained, CT scans of the chest, abdomen, and...
- NOTE: if the initial evaluation is insufficient to detect measurable disease, treating investigators may obtain a CT scan with contrast
- Participants must have bi-dimensionally measurable disease (at least one lesion with longest diameter \> 1.5 cm)
- Participants must not have had prior systemic therapy for follicular lymphoma. Radiation therapy for a previous diagnosis of early-stage follicular lymphoma is allowed
- Participant must be ≥ 18 years of age at the time of registration
- Participant must have Zubrod performance status of 0-2
- Participant must have a complete medical history and physical exam within 28 days prior to registration
- Leukocytes ≥ 3 x 10\^3/uL (within 28 days prior to registration)
- Hemoglobin \> 9.0 g/dL (within 28 days prior to registration)
- Absolute neutrophil count ≥ 1.5 x 10\^3/uL (within 28 days prior to registration)
- Platelets ≥ 100 x 10\^3/uL (within 28 days prior to registration)
- Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) unless history of Gilbert's disease. Participants with history of Gilbert's disease must have total bilirubin ≤ 5 x institutional ULN (within 28 days prior...
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 3 × institutional ULN (within 28 days prior to registration)
- Participants must have a calculated creatinine clearance ≥ 30 mL/min using the following Cockcroft-Gault Formula. This specimen must have been collected and processed within 28 days prior to registration
- Participants must not have an active or uncontrolled infection before initiation of study treatment in the opinion of the treating investigators
- Participants must not have uncontrolled diabetes within 14 days prior to registration in the opinion of the treating investigators
- Participants must not have uncontrolled blood pressure and hypertension within 14 days prior to registration in the opinion of the treating investigators
- Participants with known human immunodeficiency virus (HIV)-infection must be on effective anti-retroviral therapy at registration and have undetectable viral load test on the most recent test results obtained within 6...
- Participants with evidence of chronic hepatitis B virus (HBV) infection must have undetectable HBV viral load while on suppressive therapy on the most recent test results obtained within 6 months prior to registration...
- Participants must not have autoimmune disease requiring systemic immunosuppressive therapy
- Participants must not have had undergone organ transplants requiring ongoing systemic immunosuppressive therapy
- Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. Participants currently being treated for HCV infection must have undetectable HCV viral load test on the most recent...
- Participants must not have known chronic active Epstein Barr Virus infection (CAEBV); testing in asymptomatic participants is not required
- Participants must not have a positive test result for COVID-19 within seven (7) days prior to registration
- Participants must not have a prior or concurrent malignancy whose natural history or treatment (in the opinion of the treating physician) has the potential to interfere with the safety or how well it works assessment of...
- Participants must not have a history of confirmed progressive multifocal leukoencephalopathy (PML)
- Participants must not have received allogeneic stem cell transplantation
- Participants must not have a history of macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH)
- Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, must have a clinical risk assessment of cardiac function using the New York Heart Association...
- Participants must not be pregnant or nursing (nursing includes breast milk fed to an infant by any means, including from the breast, milk expressed by hand, or pumped). Individuals who are of reproductive potential must...
- Participants registered by participating United States (U.S.) sites must be offered the opportunity to participate in specimen banking. With participant consent, specimens must be collected and submitted via the...
- NOTE: As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review...
- Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- For participants with impaired decision-making capabilities, legally authorized representatives may sign and give informed consent on behalf of study participants in accordance with applicable federal, local, and...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Phoenix, Arizona, United States
- Tucson, Arizona, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Beverly Hills, California, United States
- Duarte, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- South Pasadena, California, United States
- Torrance, California, United States
- Upland, California, United States
- Aurora, Colorado, United States
- Fort Collins, Colorado, United States
- Greeley, Colorado, United States
+ 199 more site(s).
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Phoenix, Arizona, United States; Tucson, Arizona, United States; Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States and 213 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.