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A Phase III, Multicentre, Randomised, Open-label Study to Compare the Efficacy and Safety of AZD0486 Plus Rituximab Versus Chemotherapy Plus Rituximab in Previously Untreated Participants With Follicular Lymphoma (SOUNDTRACK-F1)

Status: Recruiting
Location: See all (135) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 130
Healthy Volunteers: f
View:

• 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 inclusion criteria details may apply

Locations
United States
Alaska
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Anchorage
Colorado
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Aurora
Connecticut
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New Haven
Michigan
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Ann Arbor
New York
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New York
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New York
Tennessee
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Nashville
Other Locations
Australia
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Garran
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Heidelberg
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Macquarie University
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Nedlands
Belgium
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Brussels
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Brussels
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Ghent
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Mechelen
Brazil
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Porto Alegre
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São Paulo
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São Paulo
Canada
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Barrie
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Chicoutimi
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Halifax
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Hamilton
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Montreal
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Oshawa
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Québec
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Saint-jérôme
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Toronto
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Winnipeg
China
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Beijing
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Beijing
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Beijing
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Changchun
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Changsha
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Chengdu
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Chongqing
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Fuzhou
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Guangzhou
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Guangzhou
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Guangzhou
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Hangzhou
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Hangzhou
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Harbin
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Hefei
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Lanzhou
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Nanchang
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Nanchang
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Nanjing
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Nanning
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Shandong
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Shanghai
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Shanghai
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Shenyang
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Shenyang
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Shijiazhuang
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Suzhou
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Tianjin
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Wenzhou
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Wuhan
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Xi'an
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Xiamen
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Zhengzhou
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Zhengzhou
Finland
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Helsinki
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Kuopio
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Tampere
Hong Kong Special Administrative Region
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Hong Kong
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Shatin
Hungary
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Budapest
India
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Delhi
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Delhi
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Gurugram
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Kolkata
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Nashik
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Surat
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Thiruvananthapuram
Japan
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Bunkyō City
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Chiba
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Chuo-shi
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Fukuoka
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Hirakata-shi
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Kobe
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Kōtoku
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Kumamoto
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Kurashiki-shi
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Kyoto
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Minatoku
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Okayama
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Osaka
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Sapporo
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Sapporo
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Sunto-gun
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Toyoake-shi
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Yamagata
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Yokohama
Poland
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Gliwice
Republic of Korea
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Busan
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Busan
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Goyang-si
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Jeonnam
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
Spain
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Barcelona
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Barcelona
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El Palmar
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Girona
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Las Palmas De Gran Canaria
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Madrid
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Madrid
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Oviedo
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Pamplona
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Santander
Sweden
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WITHDRAWN
Falun
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WITHDRAWN
Uppsala
Taiwan
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RECRUITING
Changhua
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Kaohsiung City
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Kaohsiung City
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Lukang Township
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Tainan
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Taipei
Thailand
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Bangkok
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Bangkok
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Chiang Mai
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Khon Kaen
Turkey
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Ankara
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Ankara
United Kingdom
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London
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London
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Newcastle Upon Tyne
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Norwich
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Nottingham
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Plymouth
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Southampton
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2031-11-26
Participants
Target number of participants: 1018
Treatments
Experimental: Rituximab, Surovatamig - A
Surovatamig regimen A plus rituximab
Experimental: Rituximab, Surovatamig - B
Surovatamig regimen B plus rituximab
Active_comparator: Chemoimmunotherapy
Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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