A Study of Surovatamig (AZD0486) Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
NCT ID: NCT06549595
Last Updated: 2026-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1015 participants
INTERVENTIONAL
2024-08-07
2031-11-26
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab, Surovatamig - A
Surovatamig regimen A plus rituximab
Surovatamig
a fully human bispecific monoclonal IgG4 antibody
Rituximab, Surovatamig - B
Surovatamig regimen B plus rituximab
Surovatamig
a fully human bispecific monoclonal IgG4 antibody
Chemoimmunotherapy
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)
R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
BR
Bendamustine, Rituximab
Interventions
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Surovatamig
a fully human bispecific monoclonal IgG4 antibody
R-CHOP
Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
R-CVP
Rituximab, Cyclophosphamide, Vincristine and Prednisone
BR
Bendamustine, Rituximab
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
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)
18 Years
130 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Chan Cheah, MBBS FRACP FRCPA DMSc
Role: PRINCIPAL_INVESTIGATOR
Sir Charles Gairdner Hospital (SCGH)
Locations
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Research Site
Garran, , Australia
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Heidelberg, , Australia
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Macquarie University, , Australia
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Nedlands, , Australia
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Mechelen, , Belgium
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Porto Alegre, , Brazil
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São Paulo, , Brazil
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São Paulo, , Brazil
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Winnipeg, Manitoba, Canada
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Halifax, Nova Scotia, Canada
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Barrie, Ontario, Canada
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Hamilton, Ontario, Canada
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Oshawa, Ontario, Canada
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Toronto, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Saint-Jérôme, Quebec, Canada
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Beijing, , China
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Beijing, , China
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Beijing, , China
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Changchun, , China
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Changsha, , China
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Chengdu, , China
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Chongqing, , China
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Fuzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Guangzhou, , China
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Hangzhou, , China
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Hangzhou, , China
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Harbin, , China
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Hefei, , China
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Lanzhou, , China
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Nanchang, , China
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Nanchang, , China
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Nanjing, , China
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Nanning, , China
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Shandong, , China
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Shanghai, , China
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Shanghai, , China
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Shenyang, , China
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Shenyang, , China
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Shijiazhuang, , China
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Suzhou, , China
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Tianjin, , China
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Wenzhou, , China
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Wuhan, , China
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Xi'an, , China
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Xiamen, , China
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Zhengzhou, , China
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Zhengzhou, , China
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Helsinki, , Finland
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Kuopio, , Finland
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Tampere, , Finland
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Hong Kong, , Hong Kong
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Shatin, , Hong Kong
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Budapest, , Hungary
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Delhi, , India
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Delhi, , India
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Gurugram, , India
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Kolkata, , India
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Nashik, , India
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Surat, , India
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Thiruvananthapuram, , India
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Bunkyō City, , Japan
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Chiba, , Japan
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Chuo-shi, , Japan
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Fukuoka, , Japan
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Hirakata-shi, , Japan
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Kobe, , Japan
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Kōtoku, , Japan
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Kumamoto, , Japan
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Kurashiki-shi, , Japan
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Kyoto, , Japan
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Minatoku, , Japan
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Okayama, , Japan
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Osaka, , Japan
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Sapporo, , Japan
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Sapporo, , Japan
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Sunto-gun, , Japan
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Toyoake-shi, , Japan
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Yamagata, , Japan
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Yokohama, , Japan
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Gliwice, , Poland
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Busan, , South Korea
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Busan, , South Korea
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Goyang-si, , South Korea
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Jeonnam, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Barcelona, , Spain
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Barcelona, , Spain
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El Palmar, , Spain
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Girona, , Spain
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Las Palmas de Gran Canaria, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Oviedo, , Spain
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Pamplona, , Spain
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Santander, , Spain
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Falun, , Sweden
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Uppsala, , Sweden
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Lukang Township, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Ankara, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Norwich, , United Kingdom
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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
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Southampton, , United Kingdom
Countries
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Central Contacts
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Other Identifiers
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2023-510098-33-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
D7401C00001
Identifier Type: -
Identifier Source: org_study_id
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