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

NCT06425302 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: CA073-1022U1111-1303-45942024-511304-16
• Study Type: interventional
• Target: 90
• Locations: 13 countries
• Sites: 56

Brief 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).

Conditions

Lymphoma, Follicular

Keywords

Follicular lymphoma; Grade 1-3a Follicular lymphoma; BMS-986369; CC-99282; Lymphoma; golcadomide

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• Best Overall Response (OR)

  Up to approximately 12 months from participant randomization

• Duration of Response (DoR)

  Up to approximately 3 years after randomization of the last participant

• Complete Response at 30 months (CR30)

  At approximately 30 months from randomization

Study Arms (3)

Rituximab + Chemotherapy

EXPERIMENTAL

R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone) or Rituximab + Bendamustine

Drug: Rituximab; Drug: Cyclophosphamide; Drug: Doxorubicin; Drug: Vincristine; Drug: Prednisone; Drug: Bendamustine

Golcadomide Dose 1 + Rituximab

EXPERIMENTAL

Drug: Golcadomide; Drug: Rituximab

Golcadomide Dose 2 + Rituximab

EXPERIMENTAL

Drug: Golcadomide; Drug: Rituximab

Interventions

Golcadomide DRUG

Specified dose on specified days

Also known as: CC-99282, BMS-986369

Golcadomide Dose 1 + Rituximab; Golcadomide Dose 2 + Rituximab

Rituximab DRUG

Specified dose on specified days

Also known as: Mabthera

Golcadomide Dose 1 + Rituximab; Golcadomide Dose 2 + Rituximab; Rituximab + Chemotherapy

Cyclophosphamide DRUG

Specified dose on specified days

Also known as: Endoxan

Rituximab + Chemotherapy

Doxorubicin DRUG

Specified dose on specified days

Also known as: Caelyx, pegylated liposomal doxorubicin, PLD

Rituximab + Chemotherapy

Vincristine DRUG

Specified dose on specified days

Rituximab + Chemotherapy

Prednisone DRUG

Specified dose on specified days

Rituximab + Chemotherapy

Bendamustine DRUG

Specified dose on specified days

Rituximab + Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Celgene: lead

Study Sites (56)

Local Institution - 0152

Birmingham, Alabama, 35294-3300, United States

Location

Local Institution - 0055

Anchorage, Alaska, 99508, United States

Location

Local Institution - 0180

Phoenix, Arizona, 85054, United States

Location

Local Institution - 0190

Tucson, Arizona, 85711, United States

Location

Local Institution - 0035

San Francisco, California, 94143, United States

Location

Local Institution - 0022

Washington D.C., District of Columbia, 20007, United States

Location

Local Institution - 0209

Fort Myers, Florida, 33901, United States

Location

Local Institution - 0005

Jacksonville, Florida, 32224, United States

Location

Local Institution - 0210

St. Petersburg, Florida, 33705, United States

Location

Local Institution - 0026

Tampa, Florida, 33606, United States

Location

Local Institution - 0208

West Palm Beach, Florida, 33401, United States

Location

Local Institution - 0019

Westwood, Kansas, 66205, United States

Location

Local Institution - 0031

Rochester, Minnesota, 55905, United States

Location

Local Institution - 0111

Henderson, Nevada, 89074, United States

Location

Local Institution - 0183

Hackensack, New Jersey, 07601, United States

Location

Local Institution - 0052

Salt Lake City, Utah, 84106, United States

Location

Local Institution - 0201

Norfolk, Virginia, 23502, United States

Location

Local Institution - 0202

Seattle, Washington, 98109, United States

Location

Local Institution - 0046

Liverpool, New South Wales, 2170, Australia

Location

Local Institution - 0070

South Brisbane, Queensland, 4101, Australia

Location

Local Institution - 0181

Traralgon, Victoria, 3844, Australia

Location

Local Institution - 0061

Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

Location

Local Institution - 0060

Rio de Janeiro, 22250-905, Brazil

Location

Local Institution - 0058

São Paulo, 04543-000, Brazil

Location

Local Institution - 0056

São Paulo, 05652-900, Brazil

Location

Local Institution - 0064

Toronto, Ontario, M5G 2M9, Canada

Location

Local Institution - 0205

Chicoutimi, Quebec, G7H 5H6, Canada

Location

Local Institution - 0049

Santiago, Santiago Metropolitan, 7500921, Chile

Location

Local Institution - 0050

Santiago, Santiago Metropolitan, 7580206, Chile

Location

Local Institution - 0101

Saint-Cloud, Hauts-de-Seine, 92210, France

Location

Local Institution - 0103

Lille, Nord, 59000, France

Location

Local Institution - 0121

Poitiers, Vienne, 86021, France

Location

Local Institution - 0118

Paris, 75010, France

Location

Local Institution - 0197

Regensburg, Bavaria, 93049, Germany

Location

Local Institution - 0188

Chemnitz, Saxony, 09116, Germany

Location

Local Institution - 0189

Dresden, 01307, Germany

Location

Local Institution - 0198

Rome, Lazio, 00133, Italy

Location

Local Institution - 0179

Rozzano, Milano, 20089, Italy

Location

Local Institution - 0076

Bologna, 40138, Italy

Location

Local Institution - 0075

Naples, 80131, Italy

Location

Local Institution - 0187

Skórzewo, Greater Poland Voivodeship, 60-185, Poland

Location

Local Institution - 0186

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

Location

Local Institution - 0185

Warsaw, Masovian Voivodeship, 01-748, Poland

Location

Local Institution - 0100

Busan, Pusan-Kwangyǒkshi, 49241, South Korea

Location

Local Institution - 0085

Seoul, Seoul-teukbyeolsi [Seoul], 03080, South Korea

Location

Local Institution - 0086

Seoul, Seoul-teukbyeolsi [Seoul], 06351, South Korea

Location

Local Institution - 0196

Palma, Balears [Baleares], 07120, Spain

Location

Local Institution - 0192

Valencia, Valenciana, Comunitat, 46017, Spain

Location

Local Institution - 0191

Madrid, 28040, Spain

Location

Local Institution - 0094

Kaohsiung City, 807, Taiwan

Location

Local Institution - 0092

Kaohsiung City, 83301, Taiwan

Location

Local Institution - 0123

Taipei, 10002, Taiwan

Location

Local Institution - 0175

Southampton, Hampshire, SO16 0YD, United Kingdom

Location

Local Institution - 0112

Canterbury, Kent, CT1 3NG, United Kingdom

Location

Local Institution - 0115

Edinburgh, Midlothian, EH4 2XU, United Kingdom

Location

Local Institution - 0105

Nottingham, NG5 1PB, United Kingdom

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

MeSH Terms

Conditions

Lymphoma, Follicular; Lymphoma

Interventions

Rituximab; Cyclophosphamide; Doxorubicin; liposomal doxorubicin; 1-dodecylpyridoxal; Vincristine; Prednisone; Bendamustine Hydrochloride

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Butyrates; Acids, Acyclic; Carboxylic Acids; Benzimidazoles

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2024
• First Posted: May 22, 2024
• Study Start: August 30, 2024
• Primary Completion (Estimated): November 23, 2026
• Study Completion (Estimated): November 27, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

DE (3); FR (4); CL (2); IT (4); PL (3); KR (3); BR (4); ES (3); TW (3); CA (2); GB (4); US (18); AU (3)