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

May 19, 2026 updated by: AstraZeneca

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)

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.

Study Overview

Status

Recruiting

Conditions

Untreated Follicular Lymphoma

Intervention / Treatment

Detailed Description

The study consists of 2 sequential parts.

Safety Run-in - this part will compare dose levels of Surovatamig (AZD0486) in combination with rituximab in order to establish the RP3D.
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

Study Type

Interventional

Enrollment (Estimated)

1018

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Australia
- - Darlinghurst, Australia, 2010
    - Not yet recruiting
    - Research Site
  - Garran, Australia, 2605
    - Recruiting
    - Research Site
  - Heidelberg, Australia, 3084
    - Recruiting
    - Research Site
  - Macquarie University, Australia, 2109
    - Recruiting
    - Research Site
  - Nedlands, Australia, 6009
    - Recruiting
    - Research Site
Belgium
- - Brussels, Belgium, 1070
    - Not yet recruiting
    - Research Site
  - Brussels, Belgium, 1090
    - Not yet recruiting
    - Research Site
  - Ghent, Belgium, 9000
    - Not yet recruiting
    - Research Site
  - Mechelen, Belgium, 2800
    - Not yet recruiting
    - Research Site
Brazil
- - Porto Alegre, Brazil, 90035-003
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 04501-000
    - Recruiting
    - Research Site
  - São Paulo, Brazil, 05652-900
    - Recruiting
    - Research Site
Canada
- Manitoba
  - Winnipeg, Manitoba, Canada, R3E 0V9
    - Not yet recruiting
    - Research Site
- Nova Scotia
  - Halifax, Nova Scotia, Canada, B3H 2Y9
    - Recruiting
    - Research Site
- Ontario
  - Barrie, Ontario, Canada, L4M 6M2
    - Withdrawn
    - Research Site
  - Hamilton, Ontario, Canada, L8V 5C2
    - Recruiting
    - Research Site
  - Oshawa, Ontario, Canada, L1G 2B9
    - Recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5G 1X6
    - Recruiting
    - Research Site
- Quebec
  - Chicoutimi, Quebec, Canada, G7H 5H6
    - Recruiting
    - Research Site
  - Montreal, Quebec, Canada, H4J 1C5
    - Recruiting
    - Research Site
  - Québec, Quebec, Canada, G1J 1Z4
    - Recruiting
    - Research Site
  - Saint-Jérôme, Quebec, Canada, J7Z 2V4
    - Recruiting
    - Research Site
China
- - Beijing, China, 100044
    - Recruiting
    - Research Site
  - Beijing, China, 100142
    - Recruiting
    - Research Site
  - Beijing, China, 100730
    - Not yet recruiting
    - Research Site
  - Changchun, China, 130021
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410013
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610078
    - Recruiting
    - Research Site
  - Chongqing, China, 400030
    - Recruiting
    - Research Site
  - Fuzhou, China, 350001
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510060
    - Recruiting
    - Research Site
  - Guangzhou, China, 510000
    - Recruiting
    - Research Site
  - Guangzhou, China, 510100
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310022
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310003
    - Recruiting
    - Research Site
  - Harbin, China, 150081
    - Recruiting
    - Research Site
  - Hefei, China, 230031
    - Recruiting
    - Research Site
  - Lanzhou, China, 730000
    - Recruiting
    - Research Site
  - Nanchang, China, 330006
    - Recruiting
    - Research Site
  - Nanchang, China, 330029
    - Recruiting
    - Research Site
  - Nanjing, China, 210029
    - Not yet recruiting
    - Research Site
  - Nanning, China, 530021
    - Recruiting
    - Research Site
  - Shandong, China, 250117
    - Recruiting
    - Research Site
  - Shanghai, China, 200065
    - Recruiting
    - Research Site
  - Shanghai, China, 20032
    - Recruiting
    - Research Site
  - Shenyang, China, 110001
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110004
    - Recruiting
    - Research Site
  - Shijiazhuang, China, 054001
    - Not yet recruiting
    - Research Site
  - Suzhou, China, 215006
    - Recruiting
    - Research Site
  - Tianjin, China, 300020
    - Recruiting
    - Research Site
  - Wenzhou, China, 325000
    - Not yet recruiting
    - Research Site
  - Wuhan, China, 430079
    - Recruiting
    - Research Site
  - Xi'an, China, 710061
    - Recruiting
    - Research Site
  - Xiamen, China, 361003
    - Recruiting
    - Research Site
  - Zhengzhou, China, 450000
    - Not yet recruiting
    - Research Site
  - Zhengzhou, China, 450008
    - Recruiting
    - Research Site
Czechia
- - Brno, Czechia, 625 00
    - Not yet recruiting
    - Research Site
  - Hradec Králové, Czechia, 500 05
    - Not yet recruiting
    - Research Site
  - Prague, Czechia, 12808
    - Not yet recruiting
    - Research Site
Denmark
- - Aalborg, Denmark, 9100
    - Not yet recruiting
    - Research Site
  - Copenhagen, Denmark, 2100
    - Not yet recruiting
    - Research Site
  - Odense C, Denmark, 5000
    - Not yet recruiting
    - Research Site
  - Roskilde, Denmark, 4000
    - Not yet recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00029
    - Withdrawn
    - Research Site
  - Kuopio, Finland, 70029
    - Withdrawn
    - Research Site
  - Tampere, Finland, 33520
    - Withdrawn
    - Research Site
Hong Kong
- - Hong Kong, Hong Kong, 999077
    - Recruiting
    - Research Site
  - Shatin, Hong Kong, 00000
    - Recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1122
    - Withdrawn
    - Research Site
  - Budapest, Hungary, 1088
    - Not yet recruiting
    - Research Site
  - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Research Site
  - Győr, Hungary, 9024
    - Not yet recruiting
    - Research Site
  - Kaposvár, Hungary, 7400
    - Not yet recruiting
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Not yet recruiting
    - Research Site
  - Pécs, Hungary, 7624
    - Not yet recruiting
    - Research Site
  - Szeged, Hungary, 6725
    - Not yet recruiting
    - Research Site
India
- - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110085
    - Not yet recruiting
    - Research Site
  - Gurugram, India, 122002
    - Not yet recruiting
    - Research Site
  - Kolkata, India, 700160
    - Not yet recruiting
    - Research Site
  - Nashik, India, 422002
    - Not yet recruiting
    - Research Site
  - Surat, India, 396007
    - Not yet recruiting
    - Research Site
  - Thiruvananthapuram, India, 695011
    - Not yet recruiting
    - Research Site
Japan
- - Bunkyō City, Japan, 113-8677
    - Recruiting
    - Research Site
  - Chiba, Japan, 260-8717
    - Recruiting
    - Research Site
  - Chuo-shi, Japan, 409-3898
    - Recruiting
    - Research Site
  - Fukuoka, Japan, 812-8582
    - Recruiting
    - Research Site
  - Hirakata-shi, Japan, 573-1191
    - Recruiting
    - Research Site
  - Kobe, Japan, 650-0047
    - Recruiting
    - Research Site
  - Kumamoto, Japan, 860-8556
    - Recruiting
    - Research Site
  - Kurashiki-shi, Japan, 710-8602
    - Recruiting
    - Research Site
  - Kyoto, Japan, 602-8566
    - Recruiting
    - Research Site
  - Kōtoku, Japan, 135-8550
    - Recruiting
    - Research Site
  - Minatoku, Japan, 105-8470
    - Recruiting
    - Research Site
  - Okayama, Japan, 700-8558
    - Recruiting
    - Research Site
  - Osaka, Japan, 541-8567
    - Recruiting
    - Research Site
  - Sapporo, Japan, 060-8638
    - Recruiting
    - Research Site
  - Sapporo, Japan, 003-0006
    - Recruiting
    - Research Site
  - Sunto-gun, Japan, 411-8777
    - Recruiting
    - Research Site
  - Toyoake-shi, Japan, 470-1192
    - Recruiting
    - Research Site
  - Yamagata, Japan, 990-9585
    - Recruiting
    - Research Site
  - Yokohama, Japan, 241-8515
    - Recruiting
    - Research Site
Poland
- - Gliwice, Poland, 44-102
    - Withdrawn
    - Research Site
Puerto Rico
- - San Juan, Puerto Rico, 00918
    - Not yet recruiting
    - Research Site
South Korea
- - Busan, South Korea, 49201
    - Recruiting
    - Research Site
  - Busan, South Korea, 49241
    - Recruiting
    - Research Site
  - Goyang-si, South Korea, 10408
    - Recruiting
    - Research Site
  - Jeonnam, South Korea, 519-763
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03080
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06351
    - Recruiting
    - Research Site
  - Seoul, South Korea, 05505
    - Recruiting
    - Research Site
  - Seoul, South Korea, 03722
    - Recruiting
    - Research Site
  - Seoul, South Korea, 06591
    - Recruiting
    - Research Site
Spain
- - Barcelona, Spain, 08035
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 8036
    - Not yet recruiting
    - Research Site
  - El Palmar, Spain, 30120
    - Not yet recruiting
    - Research Site
  - Girona, Spain, 17007
    - Not yet recruiting
    - Research Site
  - Las Palmas de Gran Canaria, Spain, 35020
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28041
    - Not yet recruiting
    - Research Site
  - Oviedo, Spain, 33011
    - Not yet recruiting
    - Research Site
  - Pamplona, Spain, 31008
    - Not yet recruiting
    - Research Site
  - Santander, Spain, 39008
    - Not yet recruiting
    - Research Site
Sweden
- - Falun, Sweden, 79182
    - Withdrawn
    - Research Site
  - Uppsala, Sweden, 75185
    - Withdrawn
    - Research Site
Taiwan
- - Changhua, Taiwan, 50006
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 80756
    - Recruiting
    - Research Site
  - Kaohsiung City, Taiwan, 833
    - Recruiting
    - Research Site
  - Lukang Township, Taiwan, 505029
    - Recruiting
    - Research Site
  - Tainan, Taiwan, 704
    - Recruiting
    - Research Site
  - Taipei, Taiwan, 106
    - Recruiting
    - Research Site
Thailand
- - Bangkok, Thailand, 10330
    - Recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Recruiting
    - Research Site
  - Chiang Mai, Thailand, 50200
    - Recruiting
    - Research Site
  - Khon Kaen, Thailand, 40002
    - Recruiting
    - Research Site
United Kingdom
- - London, United Kingdom, SE5 9RS
    - Recruiting
    - Research Site
  - London, United Kingdom, EC1M6BQ
    - Recruiting
    - Research Site
  - Newcastle upon Tyne, United Kingdom, NE7 7DN
    - Recruiting
    - Research Site
  - Norwich, United Kingdom, NR4 7UY
    - Recruiting
    - Research Site
  - Nottingham, United Kingdom, NG5 1PB
    - Recruiting
    - Research Site
  - Plymouth, United Kingdom, PL6 8DH
    - Recruiting
    - Research Site
  - Southampton, United Kingdom, SO16 6YD
    - Not yet recruiting
    - Research Site
United States
- Alabama
  - Huntsville, Alabama, United States, 35805
    - Not yet recruiting
    - Research Site
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Not yet recruiting
    - Research Site
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Not yet recruiting
    - Research Site
- California
  - Clovis, California, United States, 93611
    - Not yet recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Research Site
  - San Diego, California, United States, 92121
    - Not yet recruiting
    - Research Site
  - Santa Monica, California, United States, 90404
    - Not yet recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80045
    - Withdrawn
    - Research Site
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Not yet recruiting
    - Research Site
- Delaware
  - Newark, Delaware, United States, 19713
    - Not yet recruiting
    - Research Site
- Florida
  - Jacksonville, Florida, United States, 32224
    - Not yet recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30322
    - Not yet recruiting
    - Research Site
  - Macon, Georgia, United States, 31201
    - Not yet recruiting
    - Research Site
- Illinois
  - Evanston, Illinois, United States, 60201
    - Not yet recruiting
    - Research Site
  - Peoria, Illinois, United States, 61615
    - Not yet recruiting
    - Research Site
- Indiana
  - Fort Wayne, Indiana, United States, 46804
    - Not yet recruiting
    - Research Site
- Iowa
  - Des Moines, Iowa, United States, 50309
    - Not yet recruiting
    - Research Site
  - Iowa City, Iowa, United States, 52242
    - Not yet recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40536
    - Not yet recruiting
    - Research Site
  - Louisville, Kentucky, United States, 40207
    - Not yet recruiting
    - Research Site
- Louisiana
  - Baton Rouge, Louisiana, United States, 70808
    - Not yet recruiting
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21201
    - Not yet recruiting
    - Research Site
  - Bethesda, Maryland, United States, 20817
    - Not yet recruiting
    - Research Site
  - Columbia, Maryland, United States, 21044
    - Not yet recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Research Site
  - Boston, Massachusetts, United States, 02215
    - Not yet recruiting
    - Research Site
- Michigan
  - Ann Arbor, Michigan, United States, 48109
    - Not yet recruiting
    - Research Site
  - Detroit, Michigan, United States, 48201
    - Not yet recruiting
    - Research Site
  - Ypsilanti, Michigan, United States, 48197
    - Not yet recruiting
    - Research Site
- Minnesota
  - Saint Paul, Minnesota, United States, 55102
    - Not yet recruiting
    - Research Site
- Missouri
  - Springfield, Missouri, United States, 65807
    - Not yet recruiting
    - Research Site
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Not yet recruiting
    - Research Site
  - New Brunswick, New Jersey, United States, 08901
    - Not yet recruiting
    - Research Site
- New York
  - New Hyde Park, New York, United States, 11042
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10016
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10032
    - Not yet recruiting
    - Research Site
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Not yet recruiting
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Not yet recruiting
    - Research Site
- Ohio
  - Blue Ash, Ohio, United States, 45242
    - Not yet recruiting
    - Research Site
  - Columbus, Ohio, United States, 43210
    - Not yet recruiting
    - Research Site
- Oregon
  - Eugene, Oregon, United States, 97401
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - Not yet recruiting
    - Research Site
- Tennessee
  - Nashville, Tennessee, United States, 37203
    - Not yet recruiting
    - Research Site
- Texas
  - Shenandoah, Texas, United States, 77380
    - Not yet recruiting
    - Research Site
  - Tyler, Texas, United States, 75702
    - Not yet recruiting
    - Research Site
- Utah
  - Salt Lake City, Utah, United States, 84112
    - Not yet recruiting
    - Research Site
- Virginia
  - Fairfax, Virginia, United States, 22031
    - Not yet recruiting
    - Research Site
  - Richmond, Virginia, United States, 23219
    - Not yet recruiting
    - Research Site
- Washington
  - Tacoma, Washington, United States, 98405
    - Not yet recruiting
    - Research Site
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - Not yet recruiting
    - Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion 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 inclusion criteria details may apply

Exclusion Criteria:

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 interfere with the evaluation of safety
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 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
Known history of hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS)

The above is a summary, other exclusion criteria details may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rituximab, Surovatamig - A Surovatamig regimen A plus rituximab	Drug: Surovatamig a fully human bispecific monoclonal IgG4 antibody Other Names: AZD0486
Experimental: Rituximab, Surovatamig - B Surovatamig regimen B plus rituximab	Drug: Surovatamig a fully human bispecific monoclonal IgG4 antibody Other Names: AZD0486
Active Comparator: Chemoimmunotherapy Investigator's choice between 3 standard immunochemotherapy regimen (R-CHOP, R-CVP, or B-R followed by rituximab maintenance)	Drug: R-CHOP Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone Drug: R-CVP Rituximab, Cyclophosphamide, Vincristine and Prednisone Drug: BR Bendamustine, Rituximab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SRI Primary: Incidence, nature and severity of AEs and SAEs. Incidence and nature of study drug discontinuations, dose reductions, and dose delays due to AEs Time Frame: Up to 10 years	Frequency, severity, and relationship to study drug of AEs and SAEs; dose modifications; changes in physical examination and safety procedures.	Up to 10 years
SRI Primary: Determination of the recommended Phase III dose (RP3D) Time Frame: Up to 1 year	The RP3D will be the dose of Surovatamig selected for the Phase 3 part based on safety data compiled during the safety run-in part	Up to 1 year
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy Time Frame: Up to 10 years	PFS, based on Lugano 2014 Response Criteria, as assessed by BICR.	Up to 10 years
Phase 3 Dual Primary: To demonstrate the superiority of Surovatamig plus rituximab compared to Investigator's choice of SoC chemoimmunotherapy Time Frame: Up to 10 years	ORR at EoI, based on Lugano 2014 Response Criteria, as assessed by BICR.	Up to 10 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Run In and Phase 3: CR Rate Time Frame: Up to 10 years	CR rate is defined as the proportion of participants achieving a CR at any time as based on Lugano 2014 Response Criteria	Up to 10 years
Safety Run In and Phase 3: CR at EoI Time Frame: Up to 10 years	Proportion of participants achieving CR at End of Induction based on Lugano 2014 Response Criteria	Up to 10 years
Safety Run In and Phase 3: OS Time Frame: Up to 10 years	OS is defined as time until the date of death	Up to 10 years
Safety Run in and Phase 3: ORR at EoI (Investigator assessed) Time Frame: Up to 10 years	ORR defined as the proportion of participants achieving either a PR or CR at End of Induction based on Lugano 2014 Response Criteria	Up to 10 years
Phase 3: CR rate at 30 months (CR30) Time Frame: Up to 30 months	Proportion of participants in CR rate at 30 months (CR30) based on Lugano 2014 Response Criteria	Up to 30 months
Safety Run In and Phase 3: DoR Time Frame: up to 10 years	DoR will be defined from the time of first response until progression based on Lugano 2014 criteria, or death due to any cause	up to 10 years
Safety Run In and Phase 3: PFS (Investigator assessed) Time Frame: Up to 10 years	PFS (Investigator assessed) is defined as time from randomization until disease progression based on Lugano 2014 Response Criteria or death due to any cause	Up to 10 years
Phase 3: Time to First Subsequent Therapy or Death (TFST) Time Frame: Up to 10 Years	TFST will be defined as the time from randomization until the start date of first subsequent anti-lymphoma therapy or death due to any cause	Up to 10 Years
Phase 3: Time from randomisation to second progression or death (PFS2) Time Frame: Up to 10 Years	PFS2 will be defined as the time from randomization until the earliest of the progression event, after first subsequent therapy, or death due to any cause	Up to 10 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Chan Cheah, MBBS FRACP FRCPA DMSc, Sir Charles Gairdner Hospital (SCGH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 7, 2024

Primary Completion (Estimated)

November 26, 2031

Study Completion (Estimated)

November 26, 2031

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 7, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Follicular Lymphoma

Additional Relevant MeSH Terms

Other Study ID Numbers

D7401C00001
2023-510098-33-00 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Active, not recruiting

Obinutuzumab, Ibrutinib, and Venetoclax for the Treatment of Previously Untreated Stage II-IV Follicular Lymphoma

Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage III Follicular Lymphoma | Ann Arbor Stage IV Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
University of Washington
Eli Lilly and Company

Recruiting

Pirtobrutinib and Mosunetuzumab for the Treatment of Relapsed/Refractory Grades 1-3A Follicular Lymphoma, PROMOTE-FL Trial

Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
National Cancer Institute (NCI)

Terminated

Rituximab and Oblimersen in Treating Patients With Stage II, Stage III, or Stage IV Follicular Non-Hodgkin's Lymphoma

Stage III Grade 1 Follicular Lymphoma | Stage III Grade 2 Follicular Lymphoma | Stage III Grade 3 Follicular Lymphoma | Stage IV Grade 1 Follicular Lymphoma | Stage IV Grade 2 Follicular Lymphoma | Stage IV Grade 3 Follicular Lymphoma

United States
Robert Lowsky
National Cancer Institute (NCI); Janssen, LP; The Leukemia and Lymphoma Society; Rising Tide Foundation

Completed

TLR9 Agonist SD-101, Ibrutinib, and Radiation Therapy in Treating Patients With Relapsed or Refractory Grade 1-3A Follicular Lymphoma

Mantle Cell Lymphoma | Marginal Zone Lymphoma | Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States
Chinese PLA General Hospital

Recruiting

Combination of Zanubrutinib, Rituximab and Venetoclax in Patients With Previously Untreated Follicular Lymphoma (ZARAV)

Ann Arbor Stage II Follicular Lymphoma | Ann Arbor Stage III Follicular Lymphoma | Ann Arbor Stage IV Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

China
Memorial Sloan Kettering Cancer Center
Fox Chase Cancer Center; Pharmacyclics LLC.

Terminated

Ibrutinib for Patients With Follicular Lymphoma Without Complete Response to Initial Chemoimmunotherapy

Follicular Lymphoma | Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade IIIa

United States
Fondazione Italiana Linfomi ONLUS

Completed

"MIRO" Molecularly Oriented Immuno-radio-therapy (FIL_MIRO)

Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade 3A

Italy
M.D. Anderson Cancer Center
National Cancer Institute (NCI)

Active, not recruiting

Acalabrutinib, Lenalidomide, and Rituximab for the Treatment of CD20 Positive Stage III-IV, Grade 1-3a Follicular Lymphoma

Grade 3a Follicular Lymphoma | Ann Arbor Stage III Grade 1 Follicular Lymphoma | Ann Arbor Stage III Grade 2 Follicular Lymphoma | Ann Arbor Stage IV Grade 1 Follicular Lymphoma | Ann Arbor Stage IV Grade 2 Follicular Lymphoma | Ann Arbor Stage III Grade 3 Follicular Lymphoma | Ann Arbor Stage...

United States
Evopoint Biosciences Inc.

Recruiting

Clinical Study of XNW5004 Tablets in the Treatment of Relapsed and Refractory Follicular Lymphoma

Follicular Lymphoma, Grade 1 | Follicular Lymphoma, Grade 2 | Follicular Lymphoma Grade 3A | Follicular Lymphoma, Grade 3

China
National Cancer Institute (NCI)

Active, not recruiting

Obinutuzumab With or Without Umbralisib, Lenalidomide, or Combination Chemotherapy in Treating Patients With Relapsed or Refractory Grade I-IIIa Follicular Lymphoma

Recurrent Follicular Lymphoma | Refractory Follicular Lymphoma | Grade 1 Follicular Lymphoma | Grade 2 Follicular Lymphoma | Grade 3a Follicular Lymphoma

United States

Clinical Trials on R-CHOP

Sun Yat-sen University

Not yet recruiting

Celecoxib Plus R-CHOP vs R-CHOP in Newly Diagnosed Advanced CD5+ DLBCL

Diffuse Large B-Cell Lymphoma (DLBCL) | CD5 Positive

China
Sun Yat-sen University

Not yet recruiting

Lisatoclax Plus R-CHOP or Pola-R-CHP in Untreated DLBCL: A Phase Ib/II Study

Diffuse Large B Cell Lymphoma (DLBCL)

China
The University of Texas Health Science Center at...

Withdrawn

Clinical Trial of Roflumilast Added to Standard Chemoimmunotherapy

Lymphoma, B-Cell

United States
AstraZeneca

Recruiting

AZD0486 1L Therapy for Elderly or Unfit Participants With LBCL (SOUNDTRACK-D2)

Large B-cell Lymphoma

China, Belgium, Australia, Canada, Japan, United Kingdom, Brazil, Poland, Hong Kong, South Korea, Turkey (Türkiye)
Second Affiliated Hospital of Nanchang University

Enrolling by invitation

A Multicenter, Prospective, Randomized, Controlled Study of Decitabine in Combination With R-CHOP for Initial Treatment of EBV+ Diffuse Large B-cell Lymphoma

Lymphoma, Large-Cell, Diffuse

China
Ruijin Hospital

Not yet recruiting

A Study Comparing C Pola R-CHP+X With CR-CHOP in the Treatment of Previously Untreated DEL Under the Guidance of Genotyping

DLBCL - Diffuse Large B Cell Lymphoma | Double Expressor Lymphoma

China
Nanjing Yoko Biomedical Co., Ltd.

Recruiting

A Study Comparing the Efficacy and Safety of G-CHOP Versus R-CHOP in Untreated Diffuse Large B-cell Lymphoma Patients

Diffuse Large B-Cell Lymphoma, Unspecified Site

China
Li Zhiming

Not yet recruiting

Zanubrutinib, Chidamide, and Rituximab Induction with or Without CHOP Versus R-CHOP in Newly Diagnosed Double-Expressor DLBCL

Double Express Diffuse Large B-cell Lymphoma | Histone Deacetylase Inhibitor | BTK Inhibitors

China
Dana-Farber Cancer Institute
Genentech, Inc.

Active, not recruiting

A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome

Richter Syndrome

United States
Ruijin Hospital

Not yet recruiting

Dynamic CtDNA-guided Targeted Therapy in DLBCL

Diffuse Large B Cell Lymphoma (DLBCL)

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

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)

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