Spots Global Cancer Trial Database for A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities
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Trial Identification
Brief Title: A Study Evaluating the Safety of Tocilizumab in Addition to Standard of Care Premedication Given Before Obinutuzumab + Chlorambucil in Participants With Untreated B-Cell Chronic Lymphocytic Leukemia (B-CLL) and Comorbidities
Official Title: A Multicenter, Double-Blind, Randomized, and Placebo-controlled Phase Ib Study Evaluating the Safety of Adding Tocilizumab to Standard Premedications Prior to Administration of Obinutuzumab in Combination With Chlorambucil in Patients With Previously Untreated B-Cell Chronic Lymphocytic Leukemia and Comorbidities
Study ID: NCT02336048
Conditions
Study Description
Brief Summary: This multicenter, double-blind, randomized, placebo-controlled study will evaluate the safety of a single infusion of tocilizumab versus placebo, administered in addition to standard premedications (antipyretic, antihistamine, and corticosteroid) prior to the first infusion of obinutuzumab administered in combination with oral chlorambucil to participants with previously untreated B-CLL who have comorbidities. All eligible participants will be treated with a total of 6 cycles of obinutuzumab + chlorambucil (cycle length = 28 days).
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Carmel medical center, Haifa, , Israel
Meir Medical Center; Heamatology Dept, Kfar Saba, , Israel
Kaplan Medical Center; Hematology Institute; Hematolgy Institute, Rehovot, , Israel
Ziv Medical Center, Zfat, , Israel
A.O. Universitaria S. Martino Di Genova; Ematologia 1, Genova, Liguria, Italy
Asst Grande Ospedale Metropolitano Niguarda; Dipartimento Di Ematologia Ed Oncologia, Milano, Lombardia, Italy
Ospedale Businco; Ematologia, Cagliari, Sardegna, Italy
Azienda Ospedaliera Di Perugia Ospedale s. Maria Della Misericordia; Oncologia Medica, Sant'Andrea Delle Fratte (PG), Umbria, Italy
RECUH, Oncology Centre of Latvia; Clinic of Chemotherapy and Heamatology, Riga, , Latvia
Hospital Universitari Vall d'Hebron; Servicio de Hematologia, Barcelona, , Spain
Hospital Clínic i Provincial; Servicio de Hematología y Oncología, Barcelona, , Spain
Hospital Univ. 12 de Octubre; Servicio de Hematologia, Madrid, , Spain
Hospital Universitario Virgen del Rocio; Servicio de Hematologia, Sevilla, , Spain
Barts & London School of Med; Medical Oncology, London, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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