A Phase 2 interventional study of Golcadomide and Rituximab in Lymphoma, Follicular, sponsored by Celgene. Active, not recruiting at 56 sites in 13 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.
Sponsored by Celgene · Phase 2, Interventional, and Treatment
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).
931 studies on the registry are indexed under Lymphoma, Follicular; 237 are open to participants now.
This study's enrollment of 95 is above the median of 48 across 797 interventional studies indexed under Lymphoma, Follicular.
Browse Lymphoma, Follicular studies →Celgene is the lead sponsor of 419 studies on the registry; 13 are open to participants now.
Of its 100 completed or terminated interventional studies of FDA-regulated products, 29 (29%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Drug: Rituximab · Drug: Cyclophosphamide · Drug: Doxorubicin · Drug: Vincristine · Drug: Prednisone · Drug: Bendamustine
Drug: Golcadomide · Drug: Rituximab
Drug: Golcadomide · Drug: Rituximab
Specified dose on specified days
Also known as: CC-99282, BMS-986369
Specified dose on specified days
Also known as: Mabthera
Specified dose on specified days
Also known as: Endoxan
Specified dose on specified days
Also known as: Caelyx, pegylated liposomal doxorubicin, PLD
Specified dose on specified days
Specified dose on specified days
Specified dose on specified days
Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014
Golcadomide + Rituximab arms only
Time frame: Up to approximately 12 months from participant randomization
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
Time frame: Up to 28 days after last dose
Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0
Time frame: Up to 28 days after last dose
Best Overall Response (OR)
Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014
Time frame: Up to approximately 12 months from participant randomization
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
Time frame: Up to approximately 3 years after randomization of the last participant
Complete Response at 30 months (CR30)
Defined as achieving CR based on Lugano criteria at 30 months from randomization
Time frame: At approximately 30 months from randomization
Complete Metabolic Response at 6 months from the randomization (CMR6)
Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization
Time frame: At approximately 6 months from randomization
Complete Metabolic Response at 12 months from the randomization (CMR12)
Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization
Time frame: At approximately 12 months from randomization
Progression Free Survival (PFS)
Defined as time from date of randomization to first occurrence of disease progression or death from any cause
Time frame: Up to approximately 3 years from randomization of last participant
Overall Survival (OS)
Defined as time from date of randomization to death from any cause
Time frame: Up to approximately 3 years from randomization of last participant
Number of participants who achieve CMR as assessed by Lugano criteria 2014
Rituximab + Chemotherapy arm only
Time frame: Up to approximately 6 months from randomization
Plan to share: Yes — BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Supporting information: Study protocol, Sap, Csr
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Celgene