Trial Title:
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
Condition:
Lymphoma, Follicular
Conditions: Official terms:
Lymphoma
Lymphoma, Follicular
Prednisone
Cyclophosphamide
Bendamustine Hydrochloride
Rituximab
Doxorubicin
Liposomal doxorubicin
Vincristine
Conditions: Keywords:
Follicular lymphoma
Grade 1-3a Follicular lymphoma
BMS-986369
CC-99282
Lymphoma
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Golcadomide
Description:
Specified dose on specified days
Arm group label:
Golcadomide Dose 1 + Rituximab
Arm group label:
Golcadomide Dose 2 + Rituximab
Other name:
CC-99282
Other name:
BMS-986369
Intervention type:
Drug
Intervention name:
Rituximab
Description:
Specified dose on specified days
Arm group label:
Golcadomide Dose 1 + Rituximab
Arm group label:
Golcadomide Dose 2 + Rituximab
Arm group label:
Rituximab + Chemotherapy
Other name:
Mabthera
Intervention type:
Drug
Intervention name:
Cyclophosphamide
Description:
Specified dose on specified days
Arm group label:
Rituximab + Chemotherapy
Other name:
Endoxan
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Specified dose on specified days
Arm group label:
Rituximab + Chemotherapy
Other name:
Caelyx
Other name:
pegylated liposomal doxorubicin
Other name:
PLD
Intervention type:
Drug
Intervention name:
Vincristine
Description:
Specified dose on specified days
Arm group label:
Rituximab + Chemotherapy
Intervention type:
Drug
Intervention name:
Prednisone
Description:
Specified dose on specified days
Arm group label:
Rituximab + Chemotherapy
Intervention type:
Drug
Intervention name:
Bendamustine
Description:
Specified dose on specified days
Arm group label:
Rituximab + Chemotherapy
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).
Criteria for eligibility:
Criteria:
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) < 1,500 cells/mm3 (1.5 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Local Institution - 0152
Address:
City:
Birmingham
Zip:
35294-3300
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0152
Facility:
Name:
Alaska Oncology and Hematology
Address:
City:
Anchorage
Zip:
99508
Country:
United States
Status:
Recruiting
Contact:
Last name:
Steven Liu, Site 0055
Phone:
907-257-9851
Facility:
Name:
Mayo Clinic in Arizona - Phoenix
Address:
City:
Phoenix
Zip:
85054
Country:
United States
Status:
Recruiting
Contact:
Last name:
Talal Hilal, Site 0180
Phone:
480-301-8000
Facility:
Name:
Local Institution - 0190
Address:
City:
Tucson
Zip:
85711
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0190
Facility:
Name:
Local Institution - 0035
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0035
Facility:
Name:
Local Institution - 0022
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0022
Facility:
Name:
Local Institution - 0209
Address:
City:
Fort Myers
Zip:
33901
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0209
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Muhamad Alhaj Moustafa, Site 0005
Phone:
904-953-2000
Facility:
Name:
Local Institution - 0210
Address:
City:
Saint Petersburg
Zip:
33705
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0210
Facility:
Name:
Tampa General Hospital
Address:
City:
Tampa
Zip:
33606
Country:
United States
Status:
Recruiting
Contact:
Last name:
Daniel Kerr, Site 0026
Phone:
813-844-7585
Facility:
Name:
Local Institution - 0208
Address:
City:
West Palm Beach
Zip:
33401
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0208
Facility:
Name:
Local Institution - 0019
Address:
City:
Fairway
Zip:
66205
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0019
Facility:
Name:
Local Institution - 0173
Address:
City:
Jefferson
Zip:
70121
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0173
Facility:
Name:
Local Institution - 0033
Address:
City:
Baltimore
Zip:
21287
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0033
Facility:
Name:
Local Institution - 0001
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0004
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0004
Facility:
Name:
Mayo Clinic in Rochester, Minnesota
Address:
City:
Rochester
Zip:
55905
Country:
United States
Status:
Recruiting
Contact:
Last name:
J. C. Villasboas, Site 0031
Phone:
507-284-4392
Facility:
Name:
Comprehensive Cancer Centers Of Nevada
Address:
City:
Henderson
Zip:
89074
Country:
United States
Status:
Recruiting
Contact:
Last name:
Edwin Kingsley, Site 0111
Phone:
702-952-1251
Facility:
Name:
John Theurer Cancer Center at Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lori Leslie, Site 0183
Phone:
201-341-5859
Facility:
Name:
Local Institution - 0020
Address:
City:
New Brunswick
Zip:
08903
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0036
Address:
City:
New York
Zip:
10029
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0036
Facility:
Name:
Local Institution - 0052
Address:
City:
Salt Lake City
Zip:
84106
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0052
Facility:
Name:
Local Institution - 0200
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0201
Address:
City:
Norfolk
Zip:
23502
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0201
Facility:
Name:
Local Institution - 0166
Address:
City:
Seattle
Zip:
98104
Country:
United States
Status:
Withdrawn
Facility:
Name:
Local Institution - 0202
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Site 0202
Facility:
Name:
Liverpool Hospital
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Ashlea Campbell, Site 0046
Phone:
0405814856
Facility:
Name:
Mater Misercordiae Hospital
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Stephen Boyle, Site 0070
Phone:
0731638111
Facility:
Name:
Latrobe Regional Health
Address:
City:
Traralgon
Zip:
3844
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Amanda Ormerod, Site 0181
Phone:
+61351738111
Facility:
Name:
Local Institution - 0061
Address:
City:
Porto Alegre
Zip:
90035-903
Country:
Brazil
Status:
Not yet recruiting
Contact:
Last name:
Site 0061
Facility:
Name:
Centro de Tratamento de Tumores Botafogo para Oncoclinicas Rio de Janeiro SA
Address:
City:
Rio de Janeiro
Zip:
22250-905
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Adriana Scheliga, Site 0060
Phone:
552199732115
Facility:
Name:
Instituto D'Or de Pesquisa e Ensino (IDOR)
Address:
City:
Sao Paulo
Zip:
04543-000
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Abel Costa, Site 0058
Phone:
+5511964999091
Facility:
Name:
Sociedade Beneficente Israelita Brasileira Hospital Albert Einstein
Address:
City:
São Paulo
Zip:
05652-900
Country:
Brazil
Status:
Recruiting
Contact:
Last name:
Guilherme Perini, Site 0056
Phone:
+5511992926463
Facility:
Name:
Princess Margaret Cancer Centre
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Robert Kridel, Site 0064
Phone:
41694645012243
Facility:
Name:
Local Institution - 0205
Address:
City:
Chicoutimi
Zip:
G7H 5H6
Country:
Canada
Status:
Not yet recruiting
Contact:
Last name:
Site 0205
Facility:
Name:
Fundacion Arturo Lopez Perez (FALP)
Address:
City:
Santiago
Zip:
7500921
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Raimundo Gazitua, Site 0049
Phone:
+56984290128
Facility:
Name:
Clínica Inmunocel
Address:
City:
Santiago
Zip:
7580206
Country:
Chile
Status:
Recruiting
Contact:
Last name:
Alejandro Berkovits, Site 0050
Phone:
997890202
Facility:
Name:
Local Institution - 0101
Address:
City:
Saint-Cloud
Zip:
92210
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0101
Facility:
Name:
Hopital Claude Huriez - CHU de Lille
Address:
City:
Lille
Zip:
59000
Country:
France
Status:
Recruiting
Contact:
Last name:
Franck Morschhauser, Site 0103
Phone:
33320445713
Facility:
Name:
Local Institution - 0121
Address:
City:
Poitiers
Zip:
86021
Country:
France
Status:
Not yet recruiting
Contact:
Last name:
Site 0121
Facility:
Name:
Hôpital Saint-Louis
Address:
City:
Paris
Zip:
75010
Country:
France
Status:
Recruiting
Contact:
Last name:
Catherine Thieblemont, Site 0118
Phone:
33142499236
Facility:
Name:
Local Institution - 0197
Address:
City:
Regensburg
Zip:
93049
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Site 0197
Facility:
Name:
Klinikum Chemnitz - Flemmingstraße
Address:
City:
Chemnitz
Zip:
09116
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Mathias Haenel, Site 0188
Phone:
4937133344500
Facility:
Name:
Gemeinschaftspraxis Hämatologie - Onkologie Freiberg-Richter, Jacobasch, Illmer, Wolf
Address:
City:
Dresden
Zip:
01307
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Thomas Illmer, Site 0189
Phone:
00493514400022
Facility:
Name:
Local Institution - 0198
Address:
City:
Rome
Zip:
00133
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0198
Facility:
Name:
Local Institution - 0179
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0179
Facility:
Name:
Local Institution - 0096
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Local Institution - 0098
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Local Institution - 0097
Address:
City:
Bari
Zip:
70124
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Local Institution - 0076
Address:
City:
Bologna
Zip:
40138
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0076
Facility:
Name:
Local Institution - 0075
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Site 0075
Facility:
Name:
Local Institution - 0104
Address:
City:
Hwasun Gun
Zip:
58128
Country:
Korea, Republic of
Status:
Withdrawn
Facility:
Name:
Pusan National University Hospital
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Ho-Jin Shin, Site 0100
Phone:
821089371258
Facility:
Name:
Seoul National University Hospital
Address:
City:
Seoul
Zip:
03080
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
YOUNGIL KOH, Site 0085
Phone:
01091175012
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Won Seog Kim, Site 0086
Phone:
82-2-3410-6548
Facility:
Name:
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Address:
City:
Bydgoszcz
Zip:
85-168
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Jaroslaw Czyz, Site 0186
Phone:
508508810
Facility:
Name:
Luxmed Onkologia sp. z o. o.
Address:
City:
Warszawa
Zip:
01-748
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Joanna Barankiewicz, Site 0185
Phone:
+48223496303
Facility:
Name:
Aidport
Address:
City:
Skórzewo
Zip:
60-185
Country:
Poland
Status:
Recruiting
Contact:
Last name:
Michal Kwiatek, Site 0187
Phone:
+48793602210
Facility:
Name:
Hospital Universitari Son Espases
Address:
City:
Palma
Zip:
07120
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Antonio Gutierrez Garcia, Site 0196
Phone:
+34871206268
Facility:
Name:
Hospital Universitario Doctor Peset
Address:
City:
Valencia
Zip:
46017
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Eva María Donato Martín, Site 0192
Phone:
34963189168
Facility:
Name:
Hospital Universitario Fundacion Jimenez Diaz.
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Raul Cordoba Mascuñano, Site 0191
Phone:
+34649694829
Facility:
Name:
Kaohsiung Medical University Chung-Ho Memorial Hospital
Address:
City:
Kaohsiung
Zip:
807
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
YI-CHANG LIU, Site 0094
Phone:
886-7-312110
Facility:
Name:
Chang Gung Memorial Hospital at Kaohsiung
Address:
City:
Kaohsiung
Zip:
83301
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Ming Chung Wang, Site 0092
Phone:
0975056053
Facility:
Name:
National Taiwan University Hospital
Address:
City:
Taipei
Zip:
10002
Country:
Taiwan
Status:
Recruiting
Contact:
Last name:
Tai-Chung Huang, Site 0123
Phone:
+886972651392
Facility:
Name:
Local Institution - 0175
Address:
City:
Southampton
Zip:
SO16 0YD
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Site 0175
Facility:
Name:
Kent and Canterbury Hospital
Address:
City:
Canterbury
Zip:
CT1 3NG
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Moya Young, Site 0112
Phone:
+441227864072
Facility:
Name:
Western General Hospital
Address:
City:
Edinburgh
Zip:
EH4 2XU
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Victoria Campbell, Site 0115
Phone:
01315371296
Facility:
Name:
City Hospital, Nottingham University Hospitals NHS Trust
Address:
City:
Nottingham
Zip:
NG5 1PB
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Mark Bishton, Site 0105
Phone:
01159691169
Start date:
August 30, 2024
Completion date:
November 27, 2028
Lead sponsor:
Agency:
Celgene
Agency class:
Industry
Source:
Celgene
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06425302
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
https://www.bmsclinicaltrials.com/us/en/clinical-trials/NCT06425302.html
