Lymphome non-hodgkinien (LNH)

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  • GOLSEEK-2

TITRE (EN) 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
PROTOCOLE ID GOLSEEK-2
CLINICAL TRIAL.gov ID NCT06425302
TYPE(S) DE CANCER Lymphome non-hodgkinien (LNH)
PHASE Phase II
TYPE D'ÉTUDE Clinique
INSTITUTION CIUSSS DU SAGUENAY – LAC-SAINT-JEAN
305, rue Saint-Vallier, CP 5006
VILLE Chicoutimi
INVESTIGATEUR(RICE) PRINCIPAL(E) Vanessa Brunet
COORDONATEUR(RICE) Marie-Claude Tremblay
marie-claude.tremblay1.reg02@ssss.gouv.qc.ca
STATUT  Actif en recrutement
CRITÈRES D'ÉLIGIBILITÉ (EN)
  • 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).
  • 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).
CRITÈRES D'EXCLUSION (EN)
  • 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.