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

Lymphoma, Follicular Clinical Trial

— GOLSEEK-2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06425302
• Other study ID #: CA073-1022
• Secondary ID: U1111-1303-45942
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: August 3, 2024
• Est. completion date: November 27, 2028

Study information

• Verified date: May 2024
• Source: Celgene
• Contact: BMS Study Connect Contact Center www.BMSStudyConnect.com
• Phone: 855-907-3286
• Email: Clinical.Trials[@]bms.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: November 27, 2028
• Est. primary completion date: November 23, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Follicular

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Local Institution - 0070	Brisbane	Queensland
Australia	Local Institution - 0046	Liverpool	New South Wales
Australia	Local Institution - 0181	Traralgon	Victoria
Brazil	Local Institution - 0061	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution - 0060	Rio de Janeiro
Brazil	Local Institution - 0058	Sao Paulo	São Paulo
Brazil	Local Institution - 0056	São Paulo
Canada	Local Institution - 0064	Toronto	Ontario
Chile	Local Institution - 0049	Santiago	Región Metropolitana De Santiago
Chile	Local Institution - 0050	Santiago	Región Metropolitana De Santiago
France	Local Institution - 0103	Lille	Nord
France	Local Institution - 0118	Paris
France	Local Institution - 0121	Poitiers	Vienne
France	Local Institution - 0101	Saint-Cloud	Hauts-de-Seine
Germany	Local Institution - 0188	Chemnitz	Sachsen
Germany	Local Institution - 0189	Dresden
Germany	Local Institution - 0197	Regensburg	Bayern
Italy	Local Institution - 0096	Bari	Puglia
Italy	Local Institution - 0097	Bari
Italy	Local Institution - 0098	Bari	Puglia
Italy	Local Institution - 0076	Bologna
Italy	Local Institution - 0075	Napoli
Italy	Local Institution - 0198	Rome	Lazio
Italy	Local Institution - 0179	Rozzano	Milano
Korea, Republic of	Local Institution - 0100	Busan	Pusan-Kwangyokshi
Korea, Republic of	Local Institution - 0104	Hwasun Gun	Jeonranamdo
Korea, Republic of	Local Institution - 0085	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Local Institution - 0086	Seoul	Seoul-teukbyeolsi [Seoul]
Poland	Local Institution - 0186	Bydgoszcz	Kujawsko-pomorskie
Poland	Local Institution - 0187	Skorzewo	Wielkopolskie
Poland	Local Institution - 0185	Warszawa	Mazowieckie
Spain	Local Institution - 0191	Madrid
Spain	Local Institution - 0196	Palma	Balears [Baleares]
Spain	Local Institution - 0192	Valencia	Valenciana, Comunitat
Taiwan	Local Institution - 0092	Kaohsiung
Taiwan	Local Institution - 0094	Kaohsiung
Taiwan	Local Institution - 0123	Taipei
United Kingdom	Local Institution - 0112	Canterbury	Kent
United Kingdom	Local Institution - 0115	Edinburgh	Midlothian
United Kingdom	Local Institution - 0105	Nottingham
United Kingdom	Local Institution - 0175	Southampton	Hampshire
United States	Local Institution - 0055	Anchorage	Alaska
United States	Local Institution - 0033	Baltimore	Maryland
United States	Local Institution - 0152	Birmingham	Alabama
United States	Local Institution - 0001	Boston	Massachusetts
United States	Local Institution - 0004	Boston	Massachusetts
United States	Local Institution - 0019	Fairway	Kansas
United States	Local Institution - 0183	Hackensack	New Jersey
United States	Local Institution - 0111	Henderson	Nevada
United States	Local Institution - 0005	Jacksonville	Florida
United States	Local Institution - 0173	Jefferson	Louisiana
United States	Local Institution - 0020	New Brunswick	New Jersey
United States	Local Institution - 0036	New York	New York
United States	Local Institution - 0200	Norfolk	Virginia
United States	Local Institution - 0201	Norfolk	Virginia
United States	Local Institution - 0013	Peoria	Illinois
United States	Local Institution - 0180	Phoenix	Arizona
United States	Local Institution - 0031	Rochester	Minnesota
United States	Local Institution - 0052	Salt Lake City	Utah
United States	Local Institution - 0035	San Francisco	California
United States	Local Institution - 0166	Seattle	Washington
United States	Local Institution - 0202	Seattle	Washington
United States	Local Institution - 0026	Tampa	Florida
United States	Local Institution - 0190	Tucson	Arizona
United States	Local Institution - 0022	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Chile,  France,  Germany,  Italy,  Korea, Republic of,  Poland,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014	Golcadomide + Rituximab arms only	Up to approximately 12 months from participant randomization
Secondary	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
Secondary	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
Secondary	Best Overall Response (OR)	Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014	Up to approximately 12 months from participant randomization
Secondary	Duration of Response (DoR)	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	Up to approximately 3 years after randomization of the last participant
Secondary	Complete Response at 30 months (CR30)	Defined as achieving CR based on Lugano criteria at 30 months from randomization	At approximately 30 months from randomization
Secondary	Complete Metabolic Response at 6 months from the randomization (CMR6)	Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization	At approximately 6 months from randomization
Secondary	Complete Metabolic Response at 12 months from the randomization (CMR12)	Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization	At approximately 12 months from randomization
Secondary	Progression Free Survival (PFS)	Defined as time from date of randomization to first occurrence of disease progression or death from any cause	Up to approximately 3 years from randomization of last participant
Secondary	Overall Survival (OS)	Defined as time from date of randomization to death from any cause	Up to approximately 3 years from randomization of last participant
Secondary	Number of participants who achieve CMR as assessed by Lugano criteria 2014	Rituximab + Chemotherapy arm only	Up to approximately 6 months from randomization

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting