A Study of AZD0486 Plus Rituximab in Previously Untreated Follicular Lymphoma Patients
NCT ID: NCT06549595
Last Updated: 2025-11-10
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 AZD0486 in combination with rituximab in order to establish the RP3D.
2. Phase III - The Phase III part will assess the superiority of 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 AZD0486 plus rituximab Schedule A
2. Arm B: treatment with AZD0486 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 and B-R + rituximab maintenance
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rituximab, AZD0486 - A
AZD0486 regimen A plus rituximab
AZD0486
a fully human bispecific monoclonal IgG4 antibody
Rituximab, AZD0486 - B
AZD0486 regimen B plus rituximab
AZD0486
a fully human bispecific monoclonal IgG4 antibody
Chemoimmunotherapy
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP or R-CVP followed by rituximab maintenance, 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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AZD0486
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
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. Presence of \>5000 circulating lymphoma cells
5. Active or uncontrolled infection requiring systemic therapy and which places participant at unacceptable risk if he/she were to participate in the study
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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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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AstraZeneca Clinical Study Information Center
Role: CONTACT
Phone: 1-877-240-9479
Email: [email protected]
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