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

Trial Status: Active

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.

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.

Washington

Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE

Trial Phase Phase I

Trial Type Basic science

Lead Organization
Amgen, Inc.

  • Primary ID 20180257
  • Secondary IDs NCI-2020-11634, 2019-004780-52
  • Clinicaltrials.gov ID NCT04521231