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New treatment option for Untreated Follicular Lymphoma
Official title A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
ClinicalTrials.gov ID: NCT06549595
What this study is testing
What is Surovatamig?
Surovatamig is an investigational medicine, being studied as a potential treatment for untreated follicular lymphoma.
Also referred to as AZD0486.
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 is a global, randomised, Phase III, multicentre, open-label study evaluating the efficacy, safety and the degree of added benefit of the Surovatamig (AZD0486) plus rituximab combination compared to Investigator's choice of 3 standard immunochemotherapy regimen, conducted in participants with untreated FL.
- 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 to 130
You may be able to join if
- Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- ECOG performance status of 0 to 2
- No prior systemic lymphoma-directed therapy
- Need for systemic treatment meeting at least 1 GELF criteria
You likely can't join if
- Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for...
- Contra-indication to BR, RCVP, and R-CHOP
- Participants with or history of CNS lymphoma
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that...
- Presence of \>5000 circulating lymphoma cells
- Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to...
See the full eligibility criteria
- Participant must be at least 18 years of age, inclusive, at the time of signing the ICF.
- Histologically confirmed diagnosis of classic FL per WHO 2022 classification
- ECOG performance status of 0 to 2
- No prior systemic lymphoma-directed therapy
- Need for systemic treatment meeting at least 1 GELF criteria
- FDG-avid and measurable disease
- Stage II to IV and FLIPI 2-5 [Phase III only]
- Adequate liver, hematological, renal and cardiac function. The above is a summary, other details may apply
- Follicular large B-cell lymphoma (WHO 2022 classification), formerly Follicular lymphoma Grade 3B (WHO 2016 classification) or suspicion for histologic transformation to high-grade/aggressive lymphoma
- Contra-indication to BR, RCVP, and R-CHOP
- Participants with or history of CNS lymphoma
- History of a clinically relevant CNS medical condition or pathology that required treatment in the preceding year, is currently symptomatic or that which the treating investigator considers to have the potential to...
- Presence of \>5000 circulating lymphoma cells
- Active or uncontrolled infection (including EBV) requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study. If a participant has a history of COVID-19 within...
- Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) The above is a summary, other exclusion criteria details may apply
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Anchorage, Alaska, United States
- Phoenix, Arizona, United States
- Clovis, California, United States
- Los Alamitos, California, United States
- San Diego, California, United States
- Santa Monica, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Newark, Delaware, United States
- Jacksonville, Florida, United States
- Atlanta, Georgia, United States
- Macon, Georgia, United States
- Evanston, Illinois, United States
- Peoria, Illinois, United States
- Fort Wayne, Indiana, United States
- Des Moines, Iowa, United States
- Iowa City, Iowa, United States
- Lexington, Kentucky, United States
- Louisville, Kentucky, United States
+ 172 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 to 130 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Anchorage, Alaska, United States; Phoenix, Arizona, United States; Clovis, California, United States; Los Alamitos, California, United States; San Diego, California, United States and 186 more location(s). 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.