A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

Last updated: June 5, 2025
Sponsor: Celgene
Overall Status: Active - Recruiting

Phase

2

Condition

Lymphoma

Follicular Lymphoma

Treatment

Vincristine

Golcadomide

Cyclophosphamide

Clinical Study ID

NCT06425302
CA073-1022
U1111-1303-4594
2024-511304-16
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to assess the efficacy and safety of golcadomide in combination with rituximab in participants with newly diagnosed advanced stage Follicular Lymphoma (FL).

Eligibility Criteria

Inclusion

Inclusion Criteria

  • Participant has histologically confirmed Grade 1, 2 or 3a follicular lymphoma (FL) or classic FL. Formalin-fixed paraffin embedded (FFPE) archival tissue from 1 year prior to screening is allowed. If more than 1 year has passed, then a fresh biopsy must be obtained to confirm the diagnosis.

  • 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

  • Clinical evidence of transformed lymphoma by investigator assessment.

  • 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.

  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Design

Total Participants: 90
Treatment Group(s): 7
Primary Treatment: Vincristine
Phase: 2
Study Start date:
August 30, 2024
Estimated Completion Date:
November 27, 2028

Connect with a study center

  • Liverpool Hospital

    Liverpool, New South Wales 2170
    Australia

    Active - Recruiting

  • Local Institution - 0046

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Local Institution - 0070

    Brisbane, Queensland 4101
    Australia

    Site Not Available

  • Mater Misercordiae Hospital

    South Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Latrobe Regional Health

    Traralgon, Victoria 3844
    Australia

    Active - Recruiting

  • Local Institution - 0181

    Traralgon, Victoria 3844
    Australia

    Site Not Available

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Active - Recruiting

  • Local Institution - 0061

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Site Not Available

  • Local Institution - 0058

    Sao Paulo, São Paulo 04543-000
    Brazil

    Site Not Available

  • Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA

    Rio de Janeiro, 22250-905
    Brazil

    Active - Recruiting

  • Local Institution - 0060

    Rio de Janeiro, 22250-905
    Brazil

    Site Not Available

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    Sao Paulo, 04543-000
    Brazil

    Active - Recruiting

  • Local Institution - 0056

    São Paulo, 05652-900
    Brazil

    Site Not Available

  • Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein

    São Paulo, 05652-900
    Brazil

    Active - Recruiting

  • Local Institution - 0064

    Toronto, Ontario M5G 2M9
    Canada

    Site Not Available

  • Princess Margaret Cancer Centre

    Toronto, Ontario M5G 2M9
    Canada

    Active - Recruiting

  • CIUSSS- saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec G7H 5H6
    Canada

    Active - Recruiting

  • Local Institution - 0205

    Chicoutimi, Quebec G7H 5H6
    Canada

    Site Not Available

  • Clínica Inmunocel

    Santiago, Región Metropolitana De Santiago 7580206
    Chile

    Active - Recruiting

  • Fundacion Arturo Lopez Perez (FALP)

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Active - Recruiting

  • Local Institution - 0049

    Santiago, Región Metropolitana De Santiago 7500921
    Chile

    Site Not Available

  • Local Institution - 0050

    Santiago, Región Metropolitana De Santiago 7580206
    Chile

    Site Not Available

  • Institut Curie - site Saint-Cloud

    Saint-Cloud, Hauts-de-Seine 92210
    France

    Active - Recruiting

  • Local Institution - 0101

    Saint-Cloud, Hauts-de-Seine 92210
    France

    Site Not Available

  • Hopital Claude Huriez - CHU de Lille

    Lille, Nord 59000
    France

    Active - Recruiting

  • Local Institution - 0103

    Lille, Nord 59000
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Poitiers

    Poitiers, Vienne 86021
    France

    Active - Recruiting

  • Local Institution - 0121

    Poitiers, Vienne 86021
    France

    Site Not Available

  • Hôpital Saint-Louis

    Paris, 75010
    France

    Active - Recruiting

  • Local Institution - 0118

    Paris, 75010
    France

    Site Not Available

  • Krankenhaus Barmherzige Brüder Regensburg

    Regensburg, Bayern 93049
    Germany

    Active - Recruiting

  • Local Institution - 0197

    Regensburg, Bayern 93049
    Germany

    Site Not Available

  • Klinikum Chemnitz - Flemmingstraße

    Chemnitz, Sachsen 09116
    Germany

    Active - Recruiting

  • Local Institution - 0188

    Chemnitz, Sachsen 09116
    Germany

    Site Not Available

  • Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf

    Dresden, 01307
    Germany

    Active - Recruiting

  • Local Institution - 0189

    Dresden, 01307
    Germany

    Site Not Available

  • Fondazione Policlinico Tor Vergata

    Rome, Lazio 00133
    Italy

    Active - Recruiting

  • Local Institution - 0198

    Rome, Lazio 00133
    Italy

    Site Not Available

  • Istituto Clinico Humanitas

    Rozzano, Milano 20089
    Italy

    Active - Recruiting

  • Local Institution - 0179

    Rozzano, Milano 20089
    Italy

    Site Not Available

  • Local Institution - 0096

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Local Institution - 0098

    Bari, Puglia 70124
    Italy

    Site Not Available

  • Local Institution - 0097

    Bari, 70124
    Italy

    Site Not Available

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola

    Bologna, 40138
    Italy

    Active - Recruiting

  • Local Institution - 0076

    Bologna, 40138
    Italy

    Site Not Available

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Napoli, 80131
    Italy

    Active - Recruiting

  • Local Institution - 0075

    Napoli, 80131
    Italy

    Site Not Available

  • Local Institution - 0104

    Hwasun Gun, Jeonranamdo 58128
    Korea, Republic of

    Site Not Available

  • Local Institution - 0100

    Busan, Pusan-Kwangyǒkshi 49241
    Korea, Republic of

    Site Not Available

  • Pusan National University Hospital

    Busan, Pusan-Kwangyǒkshi 49241
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0085

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Site Not Available

  • Local Institution - 0086

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Site Not Available

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul] 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul] 03080
    Korea, Republic of

    Active - Recruiting

  • Local Institution - 0186

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Site Not Available

  • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy

    Bydgoszcz, Kujawsko-pomorskie 85-168
    Poland

    Active - Recruiting

  • Local Institution - 0185

    Warszawa, Mazowieckie 01-748
    Poland

    Site Not Available

  • Luxmed Onkologia sp. z o. o.

    Warszawa, Mazowieckie 01-748
    Poland

    Active - Recruiting

  • Local Institution - 0187

    Skorzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Aidport

    Skórzewo, Wielkopolskie 60-185
    Poland

    Active - Recruiting

  • Local Institution - 0187

    Skórzewo, Wielkopolskie 60-185
    Poland

    Site Not Available

  • Hospital Universitari Son Espases

    Palma, Balears [Baleares] 07120
    Spain

    Active - Recruiting

  • Local Institution - 0196

    Palma, Balears [Baleares] 07120
    Spain

    Site Not Available

  • Hospital Universitario Doctor Peset

    Valencia, Valenciana, Comunitat 46017
    Spain

    Active - Recruiting

  • Local Institution - 0192

    Valencia, Valenciana, Comunitat 46017
    Spain

    Site Not Available

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040
    Spain

    Active - Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid, 28040
    Spain

    Active - Recruiting

  • Local Institution - 0191

    Madrid, 28040
    Spain

    Site Not Available

  • Chang Gung Memorial Hospital at Kaohsiung

    Kaohsiung, 83301
    Taiwan

    Active - Recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung, 807
    Taiwan

    Active - Recruiting

  • Local Institution - 0092

    Kaohsiung, 83301
    Taiwan

    Site Not Available

  • Local Institution - 0094

    Kaohsiung, 807
    Taiwan

    Site Not Available

  • Local Institution - 0123

    Taipei, 10002
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Local Institution - 0175

    Southampton, Hampshire SO16 0YD
    United Kingdom

    Site Not Available

  • Southampton General Hospital

    Southampton, Hampshire SO16 0YD
    United Kingdom

    Active - Recruiting

  • Kent and Canterbury Hospital

    Canterbury, Kent CT1 3NG
    United Kingdom

    Active - Recruiting

  • Local Institution - 0112

    Canterbury, Kent CT1 3NG
    United Kingdom

    Site Not Available

  • Local Institution - 0115

    Edinburgh, Midlothian EH4 2XU
    United Kingdom

    Site Not Available

  • Western General Hospital

    Edinburgh, Midlothian EH4 2XU
    United Kingdom

    Active - Recruiting

  • City Hospital, Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB
    United Kingdom

    Active - Recruiting

  • Local Institution - 0105

    Nottingham, NG5 1PB
    United Kingdom

    Site Not Available

  • Local Institution - 0152

    Birmingham, Alabama 35294-3300
    United States

    Site Not Available

  • Alaska Oncology and Hematology

    Anchorage, Alaska 99508
    United States

    Active - Recruiting

  • Local Institution - 0055

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Local Institution - 0180

    Phoenix, Arizona 85054
    United States

    Site Not Available

  • Mayo Clinic in Arizona - Phoenix

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona 85711
    United States

    Active - Recruiting

  • Local Institution - 0190

    Tucson, Arizona 85711
    United States

    Site Not Available

  • Local Institution - 0035

    San Francisco, California 94143
    United States

    Site Not Available

  • UCSF Helen Diller Medical Center at Parnassus Heights

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Georgetown University Medical Center

    Washington, District of Columbia 20007
    United States

    Active - Recruiting

  • Local Institution - 0022

    Washington, District of Columbia 20007
    United States

    Site Not Available

  • Florida Cancer Specialists - South

    Fort Myers, Florida 33901
    United States

    Active - Recruiting

  • Local Institution - 0209

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Local Institution - 0005

    Jacksonville, Florida 32224
    United States

    Site Not Available

  • Mayo Clinic in Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • Florida Cancer Specialists - North

    Saint Petersburg, Florida 33705
    United States

    Active - Recruiting

  • Local Institution - 0210

    Saint Petersburg, Florida 33705
    United States

    Site Not Available

  • Local Institution - 0026

    Tampa, Florida 33606
    United States

    Site Not Available

  • Tampa General Hospital

    Tampa, Florida 33606
    United States

    Active - Recruiting

  • Florida Cancer Specialists - East

    West Palm Beach, Florida 33401
    United States

    Active - Recruiting

  • Local Institution - 0208

    West Palm Beach, Florida 33401
    United States

    Site Not Available

  • Local Institution - 0013

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Local Institution - 0019

    Fairway, Kansas 66205
    United States

    Site Not Available

  • The University of Kansas Cancer Center - Westwood

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Local Institution - 0173

    Jefferson, Louisiana 70121
    United States

    Site Not Available

  • Local Institution - 0033

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • Local Institution - 0001

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 0004

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Local Institution - 0031

    Rochester, Minnesota 55905
    United States

    Site Not Available

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Comprehensive Cancer Centers Of Nevada

    Henderson, Nevada 89074
    United States

    Active - Recruiting

  • Local Institution - 0111

    Henderson, Nevada 89074
    United States

    Site Not Available

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey 07601
    United States

    Active - Recruiting

  • Local Institution - 0183

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Local Institution - 0020

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Local Institution - 0036

    New York, New York 10029
    United States

    Site Not Available

  • Local Institution - 0052

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Active - Recruiting

  • Local Institution - 0200

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Local Institution - 0201

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Local Institution - 0201

    Virginia Beach, Virginia 23456
    United States

    Site Not Available

  • Fred Hutchinson Cancer Center

    Seattle, Washington 98109
    United States

    Active - Recruiting

  • Local Institution - 0166

    Seattle, Washington 98104
    United States

    Site Not Available

  • Local Institution - 0202

    Seattle, Washington 98109
    United States

    Site Not Available

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