A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
NCT ID: NCT06425302
Last Updated: 2025-11-13
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
PHASE2
90 participants
INTERVENTIONAL
2024-08-30
2028-11-27
Brief Summary
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Detailed Description
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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 + Chemotherapy
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Rituximab
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Doxorubicin
Specified dose on specified days
Vincristine
Specified dose on specified days
Prednisone
Specified dose on specified days
Bendamustine
Specified dose on specified days
Golcadomide Dose 1 + Rituximab
Golcadomide
Specified dose on specified days
Rituximab
Specified dose on specified days
Golcadomide Dose 2 + Rituximab
Golcadomide
Specified dose on specified days
Rituximab
Specified dose on specified days
Interventions
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Golcadomide
Specified dose on specified days
Rituximab
Specified dose on specified days
Cyclophosphamide
Specified dose on specified days
Doxorubicin
Specified dose on specified days
Vincristine
Specified dose on specified days
Prednisone
Specified dose on specified days
Bendamustine
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have no prior systemic treatment for follicular lymphoma. Prior radiation therapy or surgery for previously diagnosed stage I disease is acceptable.
* Stage II to IV disease.
* Deemed to need treatment by treating investigator. Reasons for treatment can include, but are not limited to, the following:.
i) Bulky disease defined as:.
A. A nodal or extra nodal (except spleen) mass \> 7cm in its greater diameter or, involvement of at least 3 nodal or extra nodal sites (each with a diameter greater than \>3 cm).
ii) Presence of at least one of the following B symptoms:.
A. Fever (\>38°C) of unclear etiology.
B. Night sweats.
C. Weight loss greater than 10% within the prior 6 months.
iii) Splenomegaly with inferior margin below the umbilical line.
iv) Any one of the following cytopenia due to lymphoma:.
A. Platelets \<100,000 cells/mm3 (100 x 109/L).
B. Absolute neutrophil count (ANC) \< 1,000 cells/mm3 (1.0 x 109/L).
C. Hemoglobin \< 10g/dL (6.25 mmol/L).
v) Pleural or peritoneal serous effusion (irrespective of cell content).
vi) Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).
Exclusion Criteria
* Follicular Large Cell as per WHO 5th classification or Grade 3b follicular lymphoma as per WHO 4th classification.
* Participant has any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participation in the study.
18 Years
ALL
No
Sponsors
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Celgene
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 0152
Birmingham, Alabama, United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
Arizona Oncology Associates, PC - HOPE
Tucson, Arizona, United States
UCSF Helen Diller Medical Center at Parnassus Heights
San Francisco, California, United States
Georgetown University Medical Center
Washington D.C., District of Columbia, United States
Florida Cancer Specialists - South
Fort Myers, Florida, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Florida Cancer Specialists - North
St. Petersburg, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Florida Cancer Specialists - East
West Palm Beach, Florida, United States
The University of Kansas Cancer Center - Westwood
Westwood, Kansas, United States
Local Institution - 0173
Jefferson, Louisiana, United States
Local Institution - 0033
Baltimore, Maryland, United States
Local Institution - 0001
Boston, Massachusetts, United States
Local Institution - 0004
Boston, Massachusetts, United States
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota, United States
Comprehensive Cancer Centers Of Nevada
Henderson, Nevada, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, United States
Local Institution - 0020
New Brunswick, New Jersey, United States
Local Institution - 0036
New York, New York, United States
Utah Cancer Specialists
Salt Lake City, Utah, United States
Local Institution - 0200
Norfolk, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Local Institution - 0166
Seattle, Washington, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Liverpool Hospital
Liverpool, New South Wales, Australia
Mater Misercordiae Hospital
South Brisbane, Queensland, Australia
Latrobe Regional Health
Traralgon, Victoria, Australia
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Rio de Janeiro, , Brazil
Instituto D'Or de Pesquisa e Ensino (IDOR)
São Paulo, , Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
São Paulo, , Brazil
Local Institution - 0064
Toronto, Ontario, Canada
Local Institution - 0205
Chicoutimi, Quebec, Canada
Fundacion Arturo Lopez Perez (FALP)
Santiago, Santiago Metropolitan, Chile
Clínica Inmunocel
Santiago, Santiago Metropolitan, Chile
Local Institution - 0101
Saint-Cloud, Hauts-de-Seine, France
Local Institution - 0103
Lille, Nord, France
Local Institution - 0121
Poitiers, Vienne, France
Local Institution - 0118
Paris, , France
Local Institution - 0197
Regensburg, Bavaria, Germany
Local Institution - 0188
Chemnitz, Saxony, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Dresden, , Germany
Local Institution - 0096
Bari, Apulia, Italy
Local Institution - 0098
Bari, Apulia, Italy
Fondazione Policlinico Tor Vergata
Rome, Lazio, Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy
Local Institution - 0097
Bari, , Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, , Italy
Istituto Nazionale Tumori IRCCS Fondazione Pascale
Napoli, , Italy
Local Institution - 0187
Skórzewo, Greater Poland Voivodeship, Poland
Local Institution - 0186
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Local Institution - 0185
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0104
Hwasun Gun, Jeonranamdo, South Korea
Local Institution - 0100
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0085
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Samsung Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Hospital Universitari Son Espases
Palma, Balears [Baleares], Spain
Hospital Universitario Doctor Peset
Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, , Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
Chang Gung Memorial Hospital at Kaohsiung
Kaohsiung City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Kent and Canterbury Hospital
Canterbury, Kent, United Kingdom
Western General Hospital
Edinburgh, Midlothian, United Kingdom
City Hospital, Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Countries
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Central Contacts
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BMS Study Connect Contact Center www.BMSStudyConnect.com
Role: CONTACT
Phone: 855-907-3286
Email: [email protected]
First line of the email MUST contain the NCT# and Site #.
Role: CONTACT
Facility Contacts
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Site 0152
Role: primary
Steven Liu, Site 0055
Role: primary
Talal Hilal, Site 0180
Role: primary
Laurie Chen, Site 0190
Role: primary
Carrie Ho, Site 0035
Role: primary
Joseph Roswarski, Site 0022
Role: primary
Blessy Jacob, Site 0209
Role: primary
Muhamad Alhaj Moustafa, Site 0005
Role: primary
Jennifer Cultrera, Site 0210
Role: primary
Daniel Kerr, Site 0026
Role: primary
Eric Harris, Site 0208
Role: primary
Marc Hoffmann, Site 0019
Role: primary
J. C. Villasboas, Site 0031
Role: primary
Edwin Kingsley, Site 0111
Role: primary
Lori Leslie, Site 0183
Role: primary
Stephan Kendall, Site 0052
Role: primary
Celeste Ann Bremer, Site 0201
Role: primary
Christina Poh, Site 0202
Role: primary
Ashlea Campbell, Site 0046
Role: primary
Stephen Boyle, Site 0070
Role: primary
Amanda Ormerod, Site 0181
Role: primary
Laura Fogliatto, Site 0061
Role: primary
Adriana Scheliga, Site 0060
Role: primary
Abel Costa, Site 0058
Role: primary
Guilherme Perini, Site 0056
Role: primary
Raimundo Gazitua Pepper, Site 0049
Role: primary
Alejandro Berkovits, Site 0050
Role: primary
Thomas Illmer, Site 0189
Role: primary
MARIA CHRISTINA COX, Site 0198
Role: primary
Armando Santoro, Site 0179
Role: primary
Pier Luigi Zinzani, Site 0076
Role: primary
Antonio Pinto, Site 0075
Role: primary
Won Seog Kim, Site 0086
Role: primary
Antonio Gutierrez Garcia, Site 0196
Role: primary
Eva María Donato Martín, Site 0192
Role: primary
SERGIO RAMOS CILLAN, Site 0191
Role: primary
YI-CHANG LIU, Site 0094
Role: primary
Ming Chung Wang, Site 0092
Role: primary
Tai-Chung Huang, Site 0123
Role: primary
Andrew Davies, Site 0175
Role: primary
Moya Young, Site 0112
Role: primary
Victoria Campbell, Site 0115
Role: primary
Mark Bishton, Site 0105
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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U1111-1303-4594
Identifier Type: OTHER
Identifier Source: secondary_id
2024-511304-16
Identifier Type: OTHER
Identifier Source: secondary_id
CA073-1022
Identifier Type: -
Identifier Source: org_study_id