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: 2026-01-08
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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ACTIVE_NOT_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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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
Local Institution - 0055
Anchorage, Alaska, United States
Local Institution - 0180
Phoenix, Arizona, United States
Local Institution - 0190
Tucson, Arizona, United States
Local Institution - 0035
San Francisco, California, United States
Local Institution - 0022
Washington D.C., District of Columbia, United States
Local Institution - 0209
Fort Myers, Florida, United States
Local Institution - 0005
Jacksonville, Florida, United States
Local Institution - 0210
St. Petersburg, Florida, United States
Local Institution - 0026
Tampa, Florida, United States
Local Institution - 0208
West Palm Beach, Florida, United States
Local Institution - 0019
Westwood, Kansas, United States
Local Institution - 0031
Rochester, Minnesota, United States
Local Institution - 0111
Henderson, Nevada, United States
Local Institution - 0183
Hackensack, New Jersey, United States
Local Institution - 0052
Salt Lake City, Utah, United States
Local Institution - 0201
Norfolk, Virginia, United States
Local Institution - 0202
Seattle, Washington, United States
Local Institution - 0046
Liverpool, New South Wales, Australia
Local Institution - 0070
South Brisbane, Queensland, Australia
Local Institution - 0181
Traralgon, Victoria, Australia
Local Institution - 0061
Porto Alegre, Rio Grande do Sul, Brazil
Local Institution - 0060
Rio de Janeiro, , Brazil
Local Institution - 0058
São Paulo, , Brazil
Local Institution - 0056
São Paulo, , Brazil
Local Institution - 0064
Toronto, Ontario, Canada
Local Institution - 0205
Chicoutimi, Quebec, Canada
Local Institution - 0049
Santiago, Santiago Metropolitan, Chile
Local Institution - 0050
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
Local Institution - 0189
Dresden, , Germany
Local Institution - 0198
Rome, Lazio, Italy
Local Institution - 0179
Rozzano, Milano, Italy
Local Institution - 0076
Bologna, , Italy
Local Institution - 0075
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 - 0100
Busan, Pusan-Kwangyǒkshi, South Korea
Local Institution - 0085
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0086
Seoul, Seoul-teukbyeolsi [Seoul], South Korea
Local Institution - 0196
Palma, Balears [Baleares], Spain
Local Institution - 0192
Valencia, Valenciana, Comunitat, Spain
Local Institution - 0191
Madrid, , Spain
Local Institution - 0094
Kaohsiung City, , Taiwan
Local Institution - 0092
Kaohsiung City, , Taiwan
Local Institution - 0123
Taipei, , Taiwan
Local Institution - 0175
Southampton, Hampshire, United Kingdom
Local Institution - 0112
Canterbury, Kent, United Kingdom
Local Institution - 0115
Edinburgh, Midlothian, United Kingdom
Local Institution - 0105
Nottingham, , United Kingdom
Countries
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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
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