Language: BG BG
← Back to results
Recruiting Phase 3 NCT06549595

A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients

Phase 3 – large-scale trial before approval
Conditions: Untreated Follicular Lymphoma

Sponsor: AstraZeneca

trial.available_in: БГ
Overview
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.
Description
The study consists of 2 sequential parts. 1. Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D. 2. Phase III - The Phase III part will assess the superiority of Surovatamig (AZD0486) at RP3D in combination with rituximab, compared to Investigator's choice between 3 standard chemoimmunotherapy regimens. Phase 3 consists of 3 arms 1. Arm A: treatment with Surovatamig plus rituximab Schedule A 2. Arm B: treatment with Surovatamig plus rituximab Schedule B 3. Arm C (Comparator arm): one of the following standard regimens per Investigator's choice: R-CVP + rituximab maintenance, R-CHOP + rituximab maintenance or B-R + rituximab maintenance
Who can participate
Inclusion Criteria: 1. Participant must be at least 18 years of age, inclusive, at the time of signing the ICF. 2. Histologically confirmed diagnosis of classic FL per WHO 2022 classification 3. ECOG performance status of 0 to 2 4. No prior systemic lymphoma-directed therapy 5. Need for systemic treatment meeting at least 1 GELF criteria 6. FDG-avid and measurable disease 7. Stage II to IV and FLIPI 2-5 \[Phase III only\] 8. Adequate liver, hematological, renal and cardiac function. The above is a summary, other inclusion criteria details may apply Exclusion Criteria: 1. 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 2. Contra-indication to BR, RCVP, and R-CHOP 3. Participants with or history of CNS lymphoma 4. 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 interfere with the evaluation of safety 5. Presence of \>5000 circulating lymphoma cells 6. 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 1 month of C1D1 or contracts COVID while on study treatment, participant must have 2 consecutive negative tests (PCR testing is preferable) performed at least 48 hours apart prior to resuming dosing. All symptoms related to COVID-19 infection should have fully resolved before initiating or resuming treatment 7. Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS) The above is a summary, other exclusion criteria details may apply
Locations 18
Australia (1)
Research Site
Darlinghurst
NOT_YET_RECRUITING
Belgium (1)
Research Site
Brussels
NOT_YET_RECRUITING
Brazil (1)
Research Site
Porto Alegre
Canada (1)
Research Site
Winnipeg , Manitoba
NOT_YET_RECRUITING
China (1)
Research Site
Beijing
NOT_YET_RECRUITING
Finland (1)
Research Site
Helsinki
WITHDRAWN
Hong Kong (1)
Research Site
Hong Kong
Hungary (1)
Research Site
Budapest
WITHDRAWN
India (1)
Research Site
Delhi
NOT_YET_RECRUITING
Japan (1)
Research Site
Bunkyō City
Poland (1)
Research Site
Gliwice
WITHDRAWN
South Korea (1)
Research Site
Busan
Spain (1)
Research Site
Barcelona
NOT_YET_RECRUITING
Sweden (1)
Research Site
Falun
WITHDRAWN
Taiwan (1)
Research Site
Changhua
Thailand (1)
Research Site
Bangkok
United Kingdom (1)
Research Site
London
United States (1)
Research Site
Anchorage , Alaska
NOT_YET_RECRUITING
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
130 Years
Healthy volunteers
No
Start date
07.08.2024
Completion date
26.11.2031
Registry ID
NCT06549595
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.