Spots Global Cancer Trial Database for A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
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Trial Identification
Brief Title: A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
Official Title: A Phase 1b Open-Label Study Investigating the Safety and Pharmacokinetics of Administration of Subcutaneous Blinatumomab for the Treatment of Relapsed/Refractory Indolent Non-Hodgkin's Lymphoma
Study ID: NCT02961881
Conditions
Interventions
Study Description
Brief Summary: Primary Objective: • To evaluate the safety and tolerability of subcutaneous (SC) blinatumomab dose administrations Secondary Objectives: * To determine pharmacokinetics (PK) with continuous intravenous (cIV) and SC administrations * To estimate the maximum tolerated dose (MTD) tested for blinatumomab administered subcutaneously * To determine the incidence of anti-blinatumomab antibody formation following SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration Exploratory Objective: * To determine the pharmacodynamics (PD) time profiles for B-and T-lymphocytes as well as cytokine profiles during SC administration * To evaluate efficacy response following treatment with SC blinatumomab administration using Lugano criteria if positron emission tomography-computed tomography (PET/CT) is used for evaluation
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
City of Hope National Medical Center, Duarte, California, United States
Rush University Medical Center, Chicago, Illinois, United States
Hackensack University Medical Center, Hackensack, New Jersey, United States
Concord Repatriation General Hospital, Concord, New South Wales, Australia
Epworth Healthcare, East Melbourne, Victoria, Australia
St Vincents Hospital Melbourne, Fitzroy, Victoria, Australia
Hopital Henri Mondor, Créteil Cedex, , France
Hopital Saint Louis, Paris Cedex 10, , France
Universitaetsklinikum Carl Gustav Carus, Dresden, , Germany
Universitätsklinikum Frankfurt/Main, Frankfurt am Main, , Germany
Universitatsklinikum Ulm, Ulm, , Germany
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII, Bergamo, , Italy
Azienda Ospedaliera Universitaria di Bologna Policlinico S Orsola Malpighi, Bologna, , Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Brescia, , Italy
IRCCS Ospedale San Raffaele, Milano, , Italy
IRCCS Istituto Clinico Humanitas, Rozzano MI, , Italy
Leicester Royal Infirmary, Leicester, , United Kingdom
Contact Details
Name: MD
Affiliation: Amgen
Role: STUDY_DIRECTOR
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