A Study of Subcutaneous Blinatumomab Administration in Acute Lymphoblastic Leukemia (ALL) Patients

  • End date
    Jun 16, 2024
  • participants needed
  • sponsor
Updated on 11 June 2021


The study aims to evaluate the safety and tolerability of subcutaneous (SC) blinatumomab for treatment of Acute Lymphoblastic Leukemia (ALL) and to determine the maximum tolerated dose (MTD), and recommended phase 2 dose (RP2D) of SC administered blinatumomab.

Condition B Cell Precursor Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04521231
Last Modified on11 June 2021


Yes No Not Sure

Inclusion Criteria

Aged 18 years or older
Participants with B-ALL with Relapsed or Refractory disease after at least 2 cycles of chemotherapy
Relapsed or Refractory at any time after first salvage therapy or refractory relapse
Relapse at any time after hematopoietic stem cell transplant (HSCT)
Greater than 5% blasts in the bone marrow
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible
Negative pregnancy test in women of childbearing potential

Exclusion Criteria

Active ALL in the central nervous system (CNS). Presence of greater than 5 white blood cells per cubic millimeter in cerebrospinal fluid (CSF) with lymphoblasts present and or clinical signs of CNS leukemia
History or presence of clinically relevant CNS pathology such as epilepsy, childhood or adult seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome or psychosis
History of malignancy (with certain exceptions) other than ALL within 3 years prior to start of protocol-specified therapy
Allogeneic HSCT within 12 weeks before the start of protocol-specified therapy
Cancer chemotherapy within 2 weeks before the start of protocol-specified therapy
Immunotherapy within 4 weeks before start of protocol-specified therapy. Prior failed CD19 directed therapy such as prior blinatumomab or CD19 CAR T cells will be allowed, if treatment ended more than 4 weeks prior to start of protocol therapy
Currently receiving treatment in, or less than 30 days since ending treatment on another investigational study(ies)
Abnormal screening laboratory parameters
Female participant: Expected to breastfeed during treatment and for 96 hours after the last dose of treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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