Blinatumomab in adult patients with Acute Lymphoblastic Leukaemia
Research type
Research Study
Full title
A Phase 2 Single Arm, Multicentre Trial to Evaluate the Efficacy of the BiTE® Antibody Blinatumomab in Adult Subjects with Relapsed/Refractory Philadelphia Positive B-precursor Acute Lymphoblastic Leukaemia (Alcantara Study)
IRAS ID
131321
Contact name
Adele Fielding
Contact email
Sponsor organisation
Amgen Inc
Eudract number
2013-000706-36
Research summary
This study is designed to assess a new class of investigational product for the treatment of a type of leukemia called Phladelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Ph+ ALL is an aggressive malignant disease with a clear medical need for therapeutic alternatives, particularly in adults who are refractory (resistant) to or relapse (leukaemia returns) after receiving standard of care therapy.
The investigational product, blinatumomab, belongs to a new class of antibody called bispecific T-cell engagers and has been shown in previous studies to be highly active in a similar patient population.
This study will recruit Ph+ ALL patients within the hospital setting, who are relapsed or refractory to standard treatments.
After screening, eligible subjects will be treated with blinatumomab for up to a 7.5-month treatment period. This consists of an initial ‘induction’ treatment period (2 cycles of the study drug), followed by a ‘consolidation’ treatment period (up to 3 additional cycles of blinatumomab) for applicable subjects. A single cycle of blinatumomab is 6 weeks in duration, which includes 4 weeks of continuous intravenous infusion of blinatumomab followed by a 2-week treatment-free interval. During treatment subjects will first be given treatment in hospital, and then may be given the option to receive the rest of the treatment cycle at home using an infusion pump.
Screening procedures will include a lumbar puncture, bone marrow tests, blood tests and medical examinations. At the start and/or end of each treatment cycle subjects will undergo similar tests in order to assess safety and effect of the treatment.
Following the last treatment subjects will attend a safety follow-up visit, and then subjects will be followed up every 3 months for a maxiumum of 18 months . The entire duration of the study will be a maximum of 27 months for subjects completing all visits.REC name
London - Fulham Research Ethics Committee
REC reference
14/LO/0037
Date of REC Opinion
12 Feb 2014
REC opinion
Further Information Favourable Opinion