A Phase 2 Randomized, Open Label Study to Evaluate the Efficacy and Safety of Golcadomide in Combination With Rituximab in Participants With Newly Diagnosed Advanced Stage Follicular Lymphoma

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
Alaska
Alaska Oncology and Hematology
RECRUITING
Anchorage
Alabama
Local Institution - 0152
NOT_YET_RECRUITING
Birmingham
Arizona
Mayo Clinic in Arizona - Phoenix
RECRUITING
Phoenix
Arizona Oncology Associates, PC - HOPE
RECRUITING
Tucson
California
UCSF Helen Diller Medical Center at Parnassus Heights
RECRUITING
San Francisco
Washington, D.c.
Georgetown University Medical Center
RECRUITING
Washington D.c.
Florida
Florida Cancer Specialists - South
RECRUITING
Fort Myers
Mayo Clinic in Florida
RECRUITING
Jacksonville
Florida Cancer Specialists - North
RECRUITING
St. Petersburg
Tampa General Hospital
RECRUITING
Tampa
Florida Cancer Specialists - East
RECRUITING
West Palm Beach
Kansas
The University of Kansas Cancer Center - Westwood
RECRUITING
Westwood
Louisiana
Local Institution - 0173
WITHDRAWN
Jefferson
Massachusetts
Local Institution - 0001
WITHDRAWN
Boston
Local Institution - 0004
WITHDRAWN
Boston
Maryland
Local Institution - 0033
WITHDRAWN
Baltimore
Minnesota
Mayo Clinic in Rochester, Minnesota
RECRUITING
Rochester
New Jersey
John Theurer Cancer Center at Hackensack University Medical Center
RECRUITING
Hackensack
Local Institution - 0020
WITHDRAWN
New Brunswick
Nevada
Comprehensive Cancer Centers Of Nevada
RECRUITING
Henderson
New York
Local Institution - 0036
WITHDRAWN
New York
Utah
Utah Cancer Specialists
RECRUITING
Salt Lake City
Virginia
Local Institution - 0200
WITHDRAWN
Norfolk
Virginia Oncology Associates
RECRUITING
Norfolk
Washington
Fred Hutchinson Cancer Center
RECRUITING
Seattle
Local Institution - 0166
WITHDRAWN
Seattle
Other Locations
Australia
Liverpool Hospital
RECRUITING
Liverpool
Mater Misercordiae Hospital
RECRUITING
South Brisbane
Latrobe Regional Health
RECRUITING
Traralgon
Brazil
Hospital de Clinicas de Porto Alegre
RECRUITING
Porto Alegre
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
RECRUITING
Rio De Janeiro
Instituto D'Or de Pesquisa e Ensino (IDOR)
RECRUITING
São Paulo
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
RECRUITING
São Paulo
Canada
CIUSSS- saguenay-Lac-Saint-Jean
RECRUITING
Chicoutimi
Princess Margaret Cancer Centre
RECRUITING
Toronto
Chile
Clínica Inmunocel
RECRUITING
Santiago
Fundacion Arturo Lopez Perez (FALP)
RECRUITING
Santiago
France
Hopital Claude Huriez - CHU de Lille
RECRUITING
Lille
Hôpital Saint-Louis
RECRUITING
Paris
Centre Hospitalier Universitaire de Poitiers
RECRUITING
Poitiers
Institut Curie - site Saint-Cloud
RECRUITING
Saint-cloud
Germany
Klinikum Chemnitz - Flemmingstraße
RECRUITING
Chemnitz
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
RECRUITING
Dresden
Krankenhaus Barmherzige Brüder Regensburg
RECRUITING
Regensburg
Italy
Local Institution - 0096
WITHDRAWN
Bari
Local Institution - 0097
WITHDRAWN
Bari
Local Institution - 0098
WITHDRAWN
Bari
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola
RECRUITING
Bologna
Istituto Nazionale Tumori IRCCS Fondazione Pascale
RECRUITING
Napoli
Fondazione Policlinico Tor Vergata
RECRUITING
Rome
Istituto Clinico Humanitas
RECRUITING
Rozzano
Poland
Local Institution - 0186
COMPLETED
Bydgoszcz
Local Institution - 0187
ACTIVE_NOT_RECRUITING
Skórzewo
Local Institution - 0185
ACTIVE_NOT_RECRUITING
Warsaw
Republic of Korea
Pusan National University Hospital
RECRUITING
Busan
Local Institution - 0104
WITHDRAWN
Hwasun Gun
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Spain
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitari Son Espases
RECRUITING
Palma
Hospital Universitario Doctor Peset
RECRUITING
Valencia
Taiwan
Chang Gung Memorial Hospital at Kaohsiung
RECRUITING
Kaohsiung City
Kaohsiung Medical University Chung-Ho Memorial Hospital
RECRUITING
Kaohsiung City
National Taiwan University Hospital
RECRUITING
Taipei
United Kingdom
Kent and Canterbury Hospital
RECRUITING
Canterbury
Western General Hospital
RECRUITING
Edinburgh
City Hospital, Nottingham University Hospitals NHS Trust
RECRUITING
Nottingham
Southampton General Hospital
RECRUITING
Southampton
Contact Information
Primary
BMS Study Connect Contact Center www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site #.
Time Frame
Start Date: 2024-08-30
Estimated Completion Date: 2028-11-27
Participants
Target number of participants: 90
Treatments
Experimental: Rituximab + Chemotherapy
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Experimental: Golcadomide Dose 1 + Rituximab
Experimental: Golcadomide Dose 2 + Rituximab
Sponsors
Leads: Celgene

This content was sourced from clinicaltrials.gov