Trial Type
First-Line-Therapy (Metastatic Disease/Hematology)
Description for experts
A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVe) Compared to Obinutuzumab and Venetoclax (GVe) in Previously Untreated Patients with High Risk (17p-deletion, TP53- mutation or complex karyotype) Chronic Lymphocytic Leukemia (CLL)
Description for laymen
A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVe) Compared to Obinutuzumab and Venetoclax (GVe) in Previously Untreated Patients with High Risk (17p-deletion, TP53- mutation or complex karyotype) Chronic Lymphocytic Leukemia (CLL)
JSON Data
{
"short_title": "CLL16",
"data_mode": "910",
"data_mode_number": "000000040",
"official_title": null,
"accrual_state": "running",
"therapeutic_value": "not_applicable",
"therapieansatz_value": "not_applicable",
"therapieintervention_value": "not_applicable",
"therapielinie_value": "first",
"ctgov_number": null,
"eudract_number": "2020-004360-26",
"general_contact_email": "sal-aml-register@ukdd.de",
"general_contact_phone": "+49 351-45818380",
"hauptpruefer_dd_name": null,
"description_laie_de": "Eine prospektive, offene, multizentrische, randomisierte Phase-3-Studie mit Acalabrutinib, Obinutuzumab und Venetoclax (GAVe) im Vergleich zu Obinutuzumab und Venetoclax (GVe) bei zuvor unbehandelten Patienten mit chronischer lymphatischer Leuk\u00e4mie (CLL) mit hohem Risiko (17p-Deletion, TP53-Mutation oder komplexer Karyotyp)",
"description_laie_en": "A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVe) Compared to Obinutuzumab and Venetoclax (GVe) in Previously Untreated Patients with High Risk (17p-deletion, TP53- mutation or complex karyotype) Chronic Lymphocytic Leukemia (CLL)",
"description_expert_de": "Eine prospektive, offene, multizentrische, randomisierte Phase-3-Studie mit Acalabrutinib, Obinutuzumab und Venetoclax (GAVe) im Vergleich zu Obinutuzumab und Venetoclax (GVe) bei zuvor unbehandelten Patienten mit chronischer lymphatischer Leuk\u00e4mie (CLL) mit hohem Risiko (17p-Deletion, TP53-Mutation oder komplexer Karyotyp)",
"description_expert_en": "A Prospective, Open-Label, Multicenter, Randomized, Phase 3 Trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVe) Compared to Obinutuzumab and Venetoclax (GVe) in Previously Untreated Patients with High Risk (17p-deletion, TP53- mutation or complex karyotype) Chronic Lymphocytic Leukemia (CLL)",
"rechtsgrundlage_value": null,
"phase_amg_value": null,
"main_cat_id": 4,
"sub_cat_id": 29
}
