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Lymphoma, FollicularPhase 2GOLSEEK-2NCT06425302

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

A Phase 2 study testing Golcadomide, Rituximab and Cyclophosphamide in people with Lymphoma, Follicular, run by Celgene at 56 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Lymphoma, Follicular
What is being tested?
Golcadomide, Rituximab and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
56 sitesin 13 countries
Study dates
30 Aug 2024to 27 Nov 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:.
  • Bulky disease defined as:.
  • 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).
Show all 17Show fewer
  • Presence of at least one of the following B symptoms:.
  • Fever (>38°C) of unclear etiology.
  • Night sweats.
  • Weight loss greater than 10% within the prior 6 months.
  • Splenomegaly with inferior margin below the umbilical line.
  • Any one of the following cytopenia due to lymphoma:.
  • Platelets <100,000 cells/mm3 (100 x 109/L).
  • Absolute neutrophil count (ANC) < 1,000 cells/mm3 (1.0 x 109/L).
  • Hemoglobin < 10g/dL (6.25 mmol/L).
  • Pleural or peritoneal serous effusion (irrespective of cell content).
  • Any compressive syndrome (for example, but not restricted to ureteral, orbital, gastrointestinal).

Who cannot join

  • 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.

Trial locations and contacts

56 sites in 13 countries.

56 sites in 13 countries

United States18 sites

  • Local Institution - 0055

    Anchorage, Alaska, 99508

  • Local Institution - 0152

    Birmingham, Alabama, 35294-3300

  • Local Institution - 0209

    Fort Myers, Florida, 33901

  • Local Institution - 0183

    Hackensack, New Jersey, 07601

  • Local Institution - 0111

    Henderson, Nevada, 89074

  • Local Institution - 0005

    Jacksonville, Florida, 32224

  • Local Institution - 0201

    Norfolk, Virginia, 23502

  • Local Institution - 0180

    Phoenix, Arizona, 85054

  • Local Institution - 0031

    Rochester, Minnesota, 55905

  • Local Institution - 0052

    Salt Lake City, Utah, 84106

  • Local Institution - 0035

    San Francisco, California, 94143

  • Local Institution - 0202

    Seattle, Washington, 98109

  • Local Institution - 0210

    St. Petersburg, Florida, 33705

  • Local Institution - 0026

    Tampa, Florida, 33606

  • Local Institution - 0190

    Tucson, Arizona, 85711

  • Local Institution - 0022

    Washington D.C., District of Columbia, 20007

  • Local Institution - 0208

    West Palm Beach, Florida, 33401

  • Local Institution - 0019

    Westwood, Kansas, 66205

Other trials in United States

Brazil4 sites

  • Local Institution - 0061

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Local Institution - 0060

    Rio de Janeiro, 22250-905

  • Local Institution - 0058

    São Paulo, 04543-000

  • Local Institution - 0056

    São Paulo, 05652-900

Other trials in Brazil

France4 sites

  • Local Institution - 0103

    Lille, Nord, 59000

  • Local Institution - 0118

    Paris, 75010

  • Local Institution - 0121

    Poitiers, Vienne, 86021

  • Local Institution - 0101

    Saint-Cloud, Hauts-de-Seine, 92210

Other trials in France

Italy4 sites

  • Local Institution - 0076

    Bologna, 40138

  • Local Institution - 0075

    Naples, 80131

  • Local Institution - 0198

    Rome, Lazio, 00133

  • Local Institution - 0179

    Rozzano, Milano, 20089

Other trials in Italy

United Kingdom4 sites

  • Local Institution - 0112

    Canterbury, Kent, CT1 3NG

  • Local Institution - 0115

    Edinburgh, Midlothian, EH4 2XU

  • Local Institution - 0105

    Nottingham, NG5 1PB

  • Local Institution - 0175

    Southampton, Hampshire, SO16 0YD

Other trials in United Kingdom

Australia3 sites

  • Local Institution - 0046

    Liverpool, New South Wales, 2170

  • Local Institution - 0070

    South Brisbane, Queensland, 4101

  • Local Institution - 0181

    Traralgon, Victoria, 3844

Other trials in Australia

Germany3 sites

  • Local Institution - 0188

    Chemnitz, Saxony, 09116

  • Local Institution - 0189

    Dresden, 01307

  • Local Institution - 0197

    Regensburg, Bavaria, 93049

Other trials in Germany

Poland3 sites

  • Local Institution - 0186

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168

  • Local Institution - 0187

    Skórzewo, Greater Poland Voivodeship, 60-185

  • Local Institution - 0185

    Warsaw, Masovian Voivodeship, 01-748

Other trials in Poland

South Korea3 sites

  • Local Institution - 0100

    Busan, Pusan-Kwangyǒkshi, 49241

  • Local Institution - 0085

    Seoul, Seoul-teukbyeolsi [Seoul], 03080

  • Local Institution - 0086

    Seoul, Seoul-teukbyeolsi [Seoul], 06351

Other trials in South Korea

Spain3 sites

  • Local Institution - 0191

    Madrid, 28040

  • Local Institution - 0196

    Palma, Balears [Baleares], 07120

  • Local Institution - 0192

    Valencia, Valenciana, Comunitat, 46017

Other trials in Spain

Taiwan3 sites

  • Local Institution - 0094

    Kaohsiung City, 807

  • Local Institution - 0092

    Kaohsiung City, 83301

  • Local Institution - 0123

    Taipei, 10002

Other trials in Taiwan

Canada2 sites

  • Local Institution - 0205

    Chicoutimi, Quebec, G7H 5H6

  • Local Institution - 0064

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Chile2 sites

  • Local Institution - 0049

    Santiago, Santiago Metropolitan, 7500921

  • Local Institution - 0050

    Santiago, Santiago Metropolitan, 7580206

Other trials in Chile

About this study

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

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).

Keywords
Follicular lymphoma, Grade 1-3a Follicular lymphoma, BMS-986369, CC-99282, Lymphoma, golcadomide
Medical subject headings
Lymphoma, Follicular, Lymphoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GolcadomideDrug

    Also called CC-99282, BMS-986369

    Specified dose on specified days

  • RituximabDrug

    Also called Mabthera

    Specified dose on specified days

  • CyclophosphamideDrug

    Also called Endoxan

    Specified dose on specified days

  • DoxorubicinDrug

    Also called Caelyx, pegylated liposomal doxorubicin, PLD

    Specified dose on specified days

  • VincristineDrug

    Specified dose on specified days

  • PrednisoneDrug

    Specified dose on specified days

  • BendamustineDrug

    Specified dose on specified days

Study groups in NCT06425302
Study groupRoleWhat they receive
Rituximab + ChemotherapyExperimentalR-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine
Golcadomide Dose 1 + RituximabExperimentalNot described
Receives: Drug: Golcadomide; Drug: Rituximab
Golcadomide Dose 2 + RituximabExperimentalNot described
Receives: Drug: Golcadomide; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014

    Golcadomide + Rituximab arms only

    Measured: Up to approximately 12 months from participant randomization

Secondary outcomes (10)

  1. 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

    Measured: Up to 28 days after last dose

  2. Number of participants with Treatment-emergent AEs (TEAEs) as assessed by the NCI CTCAE criteria, v.5.0

    Measured: Up to 28 days after last dose

  3. Best Overall Response (OR)

    Defined as achieving CMR or partial metabolic response (PMR) based on Lugano criteria 2014

    Measured: Up to approximately 12 months from participant randomization

  4. 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

    Measured: Up to approximately 3 years after randomization of the last participant

  5. Complete Response at 30 months (CR30)

    Defined as achieving CR based on Lugano criteria at 30 months from randomization

    Measured: At approximately 30 months from randomization

  6. Complete Metabolic Response at 6 months from the randomization (CMR6)

    Defined as achieving CMR based on Lugano criteria 2014 at 6 months from randomization

    Measured: At approximately 6 months from randomization

  7. Complete Metabolic Response at 12 months from the randomization (CMR12)

    Defined as achieving CMR based on Lugano criteria 2014 at 12 months from randomization

    Measured: At approximately 12 months from randomization

  8. Progression Free Survival (PFS)

    Defined as time from date of randomization to first occurrence of disease progression or death from any cause

    Measured: Up to approximately 3 years from randomization of last participant

  9. Overall Survival (OS)

    Defined as time from date of randomization to death from any cause

    Measured: Up to approximately 3 years from randomization of last participant

  10. Number of participants who achieve CMR as assessed by Lugano criteria 2014

    Rituximab + Chemotherapy arm only

    Measured: Up to approximately 6 months from randomization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2024
  2. Study start30 Aug 2024
  3. Primary completion19 Jun 2026
  4. Study completion27 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06425302
Sponsor's protocol ID
CA073-1022
Other IDs
U1111-1303-4594, 2024-511304-16
Acronym
GOLSEEK-2
Status last verified
Jul 2026
First submitted
17 May 2024
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Golcadomide, Rituximab and Cyclophosphamide in people with Lymphoma, Follicular, run by Celgene at 56 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 56 sites in United States, Brazil, France, Italy, United Kingdom and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants who achieve complete metabolic response (CMR) as assessed by Lugano criteria 2014 (time frame: Up to approximately 12 months from participant randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06425302.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.

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