A Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma
- Conditions
- Lymphoma, Follicular
- Interventions
- Registration Number
- NCT06425302
- Lead Sponsor
- Celgene
- Brief 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rituximab + Chemotherapy Doxorubicin R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Golcadomide Dose 1 + Rituximab Rituximab - Golcadomide Dose 2 + Rituximab Golcadomide - Golcadomide Dose 2 + Rituximab Rituximab - Rituximab + Chemotherapy Cyclophosphamide R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Rituximab + Chemotherapy Rituximab R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Rituximab + Chemotherapy Vincristine R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Rituximab + Chemotherapy Prednisone R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Rituximab + Chemotherapy Bendamustine R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine Golcadomide Dose 1 + Rituximab Golcadomide -
- Primary Outcome Measures
Name Time Method Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014 Up to approximately 12 months from participant randomization Golcadomide + Rituximab arms only
- Secondary Outcome Measures
Name Time Method Number of participants with Adverse Events (AEs) as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria, v.5.0 Up to 28 days after last dose Duration of Response (DoR) Up to approximately 3 years after randomization of the last participant Defined as time from first confirmed response (Complete Response (CR) or Partial Response (PR)) to disease progression, start of new anti-lymphoma therapy, or death
Best Overall Response (OR) Up to approximately 12 months from participant randomization Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
Complete Response at 30 months (CR30) At approximately 30 months from randomization Defined as achieving CR based on Lugano criteria at 30 months from randomization
Complete Metabolic Response at 6 months from the randomization (CMR6) At approximately 6 months from randomization Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
Complete Metabolic Response at 12 months from the randomization (CMR12) At approximately 12 months from randomization Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
Progression Free Survival (PFS) Up to approximately 3 years from randomization of last participant Defined as time from date of randomization to first occurrence of disease progression or death from any cause
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0 Up to 28 days after last dose Overall Survival (OS) Up to approximately 3 years from randomization of last participant Defined as time from date of randomization to death from any cause
Number of participants who achieve CMR as assessed by Lugano criteria 2014 Up to approximately 6 months from randomization Rituximab + Chemotherapy arm only
Trial Locations
- Locations (68)
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
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, 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
🇺🇸Saint 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
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)
🇧🇷Sao Paulo, Brazil
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
🇧🇷São Paulo, Brazil
Princess Margaret Cancer Centre
🇨🇦Toronto, Ontario, Canada
CIUSSS- saguenay-Lac-Saint-Jean
🇨🇦Chicoutimi, Quebec, Canada
Fundacion Arturo Lopez Perez (FALP)
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
ClÃnica Inmunocel
🇨🇱Santiago, Región Metropolitana De Santiago, Chile
Institut Curie - site Saint-Cloud
🇫🇷Saint-Cloud, Hauts-de-Seine, France
Hopital Claude Huriez - CHU de Lille
🇫🇷Lille, Nord, France
Centre Hospitalier Universitaire de Poitiers
🇫🇷Poitiers, Vienne, France
Hôpital Saint-Louis
🇫🇷Paris, France
Krankenhaus Barmherzige Brüder Regensburg
🇩🇪Regensburg, Bayern, Germany
Klinikum Chemnitz - Flemmingstraße
🇩🇪Chemnitz, Sachsen, Germany
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
🇩🇪Dresden, Germany
Fondazione Policlinico Tor Vergata
🇮🇹Rome, Lazio, Italy
Istituto Clinico Humanitas
🇮🇹Rozzano, Milano, Italy
Local Institution - 0096
🇮🇹Bari, Puglia, Italy
Local Institution - 0098
🇮🇹Bari, Puglia, 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 - 0104
🇰🇷Hwasun Gun, Jeonranamdo, Korea, Republic of
Pusan National University Hospital
🇰🇷Busan, Pusan-Kwangyǒkshi, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Luxmed Onkologia sp. z o. o.
🇵🇱Warszawa, Mazowieckie, Poland
Aidport
🇵🇱Skórzewo, Wielkopolskie, Poland
Hospital Universitari Son Espases
🇪🇸Palma, Balears [Baleares], Spain
Hospital Universitario Doctor Peset
🇪🇸Valencia, Valenciana, Comunitat, Spain
Hospital Universitario Fundación Jiménez DÃaz
🇪🇸Madrid, Spain
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
Chang Gung Memorial Hospital at Kaohsiung
🇨🇳Kaohsiung, 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