Blinatumomab(MT103)in patients with MRD+ B-precursor ALL

• Research type

  Research Study

• Full title

  A confirmatory multicenter, single-arm study to assess the efficacy, safety, and tolerability of the BiTE® antibody blinatumomab in adult patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia

• IRAS ID

  55279

• Contact name

  Adele Kay Fielding

• Sponsor organisation

  Amgen Research (Munich) GmbH

• Eudract number

  2010-018314-75

• ISRCTN Number

  tba

• Research summary

  This study is designed to investigate the efficacy, safety and tolerability of Blinatumomab in the treatment of patients with minimal residual disease (MRD) of B-precursor acute lymphoblastic leukemia (ALL). The term minimal residual disease stands for tumor cells that have remained in the blood after chemotherapy or radiotherapy, but cannot be detected e.g. by using microscopy. These cells can proliferate again and lead to a relapse of the disease. Blinatumomab is a newly developed antibody which helps the body's own immune system destroy the leukemic cells.Male and female patients aged over 18 will be assessed for eligibility for the study. This screening process will include an assessment of their disease status by means of a bone marrow biopsy or aspiration. Cerebrospinaflud (CSF) will also be collected by lumbar puncture (also known as a spinal tap) and examined to exclude the possibility of central nervous system involvement. Patients will also undergo a physical exam, electrocardiogram (ECG) and blood & urine and tests. Patients will be asked to complete questionnaires regarding their state of health and quality of life.The study consists of three phases;1. Screening phase of about 3 weeks2. Treatment phase (a maximum of four cycles with Blinatumomab, each cycle consisting of a 4-week continuous infusion period and a 2-week infusion free period)3. Follow-up phase for two years after start of treatmentPatients will also be given standard prophylactic intrathecal chemotherapy before the start of first treatment with Blinatumomab and during cycles 2 and 4 in the treatment phase. Patients will be monitored throughout the study for their safety and tolerability to Blinatumomab.The study will be conducted in over 60 hospitals in more than 10 countries across Europe, Russia and the United States including up to six NHS hospitals in the UK.

• REC name

  London - Fulham Research Ethics Committee

• REC reference

  10/H0711/66

• Date of REC Opinion

  19 Jan 2011

• REC opinion

  Further Information Favourable Opinion