Clinical Trial 23790

• Overview

  Study Title:

  A Phase 3, Multicenter, Randomized, Open Label Study to Compare the Efficacy and Safety of Golcadomide in Combination with Rituximab (Golca + R) Vs Investigator's Choice in Participants with Relapsed/Refractory Follicular Lymphoma

  Summary:

  The study is designed as a multicenter, randomized, open label Phase 3 study to compare the efficacy and safety of golcadomide in combination with rituximab vs investigator's choice in participants with relapsed/refractory follicular lymphoma who have received at least one line of prior systemic therapy.

  Objective:

  Primary Objective: To evaluate the efficacy of Golca + R vs Investigator s choice (IC) in participants with R/R FL with respect to progression free survival (PFS-IRAC). Secondary Objective: To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to overall response rate (ORRIRAC). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to overall survival (OS). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to progression-free survival (PFSinvestigator). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to ORR (ORR- investigator). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to complete metabolic response rate (CMRR- investigator). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to the duration of response (DoR). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to the event free survival (EFS). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to time to next anti-lymphoma treatment (TTNT). To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to Progression-Free Survivalon next anti-lymphoma treatment (NALT) (PFS2). To compare the participant reported FL symptoms, functioning, and health related quality of life of Golca + R vs IC in participants with R/R FL. To evaluate the efficacy of Golca + R vs IC in participants with R/R FL with respect to MRD negativity at EOT.

• Treatments

  Therapies:

  Chemotherapy (NOS); Immunomodulators; Therapy (NOS); anti-CD20 antibody; cereblon E3 ubiquitin ligase modulating (CELMoD) agent

  Medications:

  Adriamycin (doxorubicin); Bendamustine (); CC-5013 (Lenalidomide); Golcadomide (); Lenalidomide (Revlimid); Rituxan (rituximab); Vincristine (); cyclophosphamide (); cytoxan (cyclophosphamide); doxorubicin (); prednisone (); rituximab ()

• Inclusion Criteria

  Key Inclusion Criteria:
  • Participant has histologically confirmed FL (Grade 1, 2, 3a or classic FL) as assessed by local pathology. Adequate fresh tumor biopsy tissue or archived tumor biopsy from the latest relapse if available with corresponding pathology report for retrospective central pathology confirmation of relapse, is required. Evaluation from fine needle aspirate is not permitted.
  • Relapsed or refractory disease.
  • Eastern Cooperative Oncology Group (ECOG) 0-2 (ECOG 3 authorized if it is due to lymphoma and not comorbidities).
  • Participant must have positron emission tomography (PET)-positive disease with at least one PET-positive lesion and measurable disease on cross section imaging by CT, as defined by Lugano classification.
  • Participants with an indication for anti-lymphoma treatment as per investigator assessment based on modified Groupe d'Etude des Lymphomes Folliculaires (GELF) criteria.
  • Participant has received at least 1 or more prior lines of systemic therapy with one line consisting of a combination including an anti-CD20 monoclonal antibody (eg, rituximab, obinutuzumab) and an alkylating agent (eg, cyclophosphamide, bendamustine). Prior treatment with radiation therapy does not count as a line of therapy for eligibility.
  • Lab parameters as outlined in the protocol.
  • Adequate cardiac function for participants receiving anthracycline-based chemotherapy, defined as left ventricular ejection fraction (LVEF) ≥ 45% as assessed by echocardiogram (ECHO) as standard of care or multi-gated acquisition scan (MUGA).
  • Additional criteria may apply.

• Exclusion Criteria

  Key Exclusion Criteria:
  • Evidence or history of composite Diffuse large B-cell lymphoma (DLBCL) and FL or of transformed Non-Hodgkin Lymphoma (NHL) or any other indolent lymphoma.
  • Follicular large cell as per 5th World Health Organization (WHO) sub-classification (grade 3b FL per WHO 4th classification) or duodenal-type FL.
  • Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from compliantly participating in the study based on Investigator's judgment.
  • Participant has any condition that confounds the ability to interpret data from the study based on Investigator's or Sponsor's judgment.
  • Presence or history of central nervous system (CNS) involvement by lymphoma.
  • History of stroke or intracranial hemorrhage within 6 months prior to enrollment.
  • Deep venous thrombosis/Pulmonary embolism within 1 month prior to enrollment.
  • Participants with a history of progressive multifocal leukoencephalopathy.
  • Participant has any other subtype of lymphoma.
  • Participant has persistent diarrhea or malabsorption ≥ Grade 2 (NCI CTCAE v5.0), despite medical management.
  • History of another primary malignancy that has not been in remission for ≥ 3 years except for non-invasive malignancies.
  • Other protocol-defined Inclusion/Exclusion criteria apply.
  • Additional criteria may apply.

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