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Cerca in Study Connect

Recruiting

Study to Compare the Effectiveness and Safety of Golcadomide Plus R-CHOP vs Placebo Plus R-CHOP in Participants With Previously Untreated High-risk Large B-cell Lymphoma - CA073-1020

Aggiornato: 20 giugno, 2024   |   ClinicalTrials.gov

Celgene e’ interamente controllata da Bristol-Myers Squibb Company 

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Dettagli della sperimentazione

  • Phase 3

    Fase

  • Sesso

  • 18-80

    Fascia d'età

  • 109

    Sede/i

  • Recruiting

Opzioni di trattamento

Bracci dello studio
TERAPIA ASSEGNATA
Experimental: Golcadomide + R-CHOP (Rituximab, Doxorubicin, Vincristine, Cyclophosphamide, Prednisone)
Placebo Comparator: Placebo + R-CHOP
Drug: Placebo, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone

Principali criteri di idoneità

Inclusion Criteria: - Histologically confirmed (per local evaluation) diagnosis of de novo, previously untreated large B-cell lymphoma (LBCL) according to 2022 world health organization (WHO) classification including: i) Diffuse large B-cell lymphoma (DLBCL), not otherwise specified [including germinal center B-cell (GCB) and activated B-cell (ABC) types] ii) High-grade B-cell lymphoma, with MYC and BCL2 rearrangements iii) High-grade B-cell lymphoma, not otherwise specified iv) T-cell/histiocyte/rich large B-cell lymphoma (THRLBCL) v) Epstein-Barr virus + DLBCL - International Prognostic Index (IPI) score 1 or 2 with lactate dehydrogenase (LDH) ≥ 1.3 x upper limit of normal (ULN) and/or bulky disease defined as single lesion of ≥ 7 cm OR IPI ≥ 3. - Measurable disease defined by at least 1 fluorodeoxyglucose (FDG)-avid lesion for FDG-avid subtype and 1 bi-dimensionally measurable (> 1.5 cm in longest diameter) disease by computed tomography (CT) or magnetic resonance imaging (MRI), as defined by the Lugano classification. - Must have Ann Arbor Stage II-IV disease. Exclusion Criteria: - Any significant medical condition, active infection, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study. - Any other subtype of lymphoma. Cases of primary mediastinal (thymic) large B-cell lymphoma (PMBCL), primary cutaneous DLBCL-leg type, Grade 3b FL, FL transformed to a-BCL, Anaplastic lymphoma kinase (ALK) positive large B-cell lymphoma, primary effusion lymphoma, and Burkitt lymphoma. - Documented or suspected central nervous system (CNS) involvement by lymphoma. - Other protocol-defined Inclusion/Exclusion criteria apply.

Ti consigliamo vivamente di contattare BMS per segnalare gli effetti collaterali (eventi avversi)
Qui vengono definiti gli effetti collaterali (eventi avversi) e altri eventi da segnalare
Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche

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