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NCT Number: NCT06425302

A 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).

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Local Institution - 0046, Liverpool, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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) < 1,000 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

  • 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.

Treatment and study plan

golcadomide

Drug

Specified dose on specified days

Other names: CC-99282, BMS-986369

Rituximab

Drug

Specified dose on specified days

Other names: Mabthera

Cyclophosphamide

Drug

Specified dose on specified days

Other names: Endoxan

Doxorubicin

Drug

Specified dose on specified days

Other names: Caelyx, pegylated liposomal doxorubicin, PLD

Vincristine

Drug

Specified dose on specified days

Prednisone

Drug

Specified dose on specified days

Bendamustine

Drug

Specified dose on specified days

Primary outcomes

  1. 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

    Golcadomide + Rituximab arms only

Secondary outcomes

  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

    Time frame: 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

    Time frame: Up to 28 days after last dose

  3. Best Overall Response (OR)

    Time frame: Up to approximately 12 months from participant randomization

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

  4. Duration of Response (DoR)

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

    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

  5. Complete Response at 30 months (CR30)

    Time frame: At approximately 30 months from randomization

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

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

    Time frame: At approximately 6 months from randomization

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

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

    Time frame: At approximately 12 months from randomization

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

  8. Progression Free Survival (PFS)

    Time frame: Up to approximately 3 years from randomization of last participant

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

  9. Overall Survival (OS)

    Time frame: Up to approximately 3 years from randomization of last participant

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

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

    Time frame: Up to approximately 6 months from randomization

    Rituximab + Chemotherapy arm only

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Acronym: GOLSEEK-2

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
May 22, 2024
Registry last updated
Jul 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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