Blinatumomab (MT103) in adult patients with relapsed/refractory ALL

• Research type

  Research Study

• Full title

  An open label, multicenter, phase II study to evaluate efficacy and safety of the BiTE antibody blinatumomab in adult patients with relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL)

• IRAS ID

  86161

• Contact name

  Adele Fielding

• Sponsor organisation

  Micromet GmBH

• Eudract number

  2011-002257-61

• ISRCTN Number

  Unknown

• Research summary

  This study is designed to investigate the efficacy and safety of blinatumomab in the treatment of patients with relapsed/refractory B-precursor acute lymphoblastic leukaemia (ALL). Relapsed/refractory B-precursor ALL in adult patients is an aggressive malignant disease with dismal prognosis. Several studies have reported long term survival to be below 10%. Major prognostic factors are duration of first complete remission (CR1) and age. With current salvage chemotherapy, complete remission (CR) rate is low (20 to 30%) in patients in first salvage with short duration (< one year) of first remission, patients relapsed after first salvage, or patients aged 60 years and older.Blinatumomab is a newly developed antibody that helps the body's own immune system destroy the leukaemic cells. Male and female patients aged over 18 will be assessed for eligibility for the study. The 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. A CT scan maybe conducted as part of the assessment by Cheson Criteria if deemed necessary by the Investigator. Patients will also undergo a physical exam, electrocardiogram (ECG), blood and urine tests. The study will consist of three phases;1. Screening phase of up to 3 weeks2. 2. Treatment phase (a maximum of 5 cycles with blinatumomab, each cycle consisting of a 4-week continuous infusion period followed by a 2-week infusion free period) 3. 3. Follow-up phase for up to 3 years after start of treatment Patients will also be given standard prophylactic intrathecal chemotherapy before the start of first treatment with blinatumomab and at the end of any subsequent cycle. Safety will be monitored throughout the study.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  11/LO/1733

• Date of REC Opinion

  20 Feb 2012

• REC opinion

  Further Information Favourable Opinion