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

  • STATUS
    Recruiting
  • End date
    Apr 8, 2024
  • participants needed
    80
  • sponsor
    Amgen
Updated on 9 September 2021

Summary

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.

Details
Condition B Cell Precursor Acute Lymphoblastic Leukemia
Treatment Blinatumomab
Clinical Study IdentifierNCT04521231
SponsorAmgen
Last Modified on9 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Aged 18 years or older
Participants with B-precursor ALL with Relapsed or Refractory disease with any of the
Relapsed or Refractory at any time after first salvage therapy or refractory relapse
following
Refractory to primary induction therapy or refractory to salvage therapy
In untreated first, second, third or greater relapse or refractory relapse
First Relapse is defined as achievement of first Complete Remission (CR) [CR1] during upfront therapy then relapse during or after continuation therapy
Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to 2
Primary Refractory disease is defined as the absence of CR after standard induction therapy
Participants with relapse or refractory B Cell ALL Ph+ disease and that are intolerant or refractory to prior tyrosine kinase inhibitors (TKIs) are eligible
Refractory relapse is defined as lack of CR after salvage treatment
Second relapse or later relapse is defined
Relapse at any time after allogenic hematopoietic stem cell transplant (HSCT)
Greater than or equal to 5% blasts in the Bone Marrow
Participants with CR2 or greater with a BM blast count of at least 0.1% (10-3)
The above is a summary, other inclusion criteria details may apply

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
Symptoms and/or signs that indicate an acute or uncontrolled chronic infection
The above is a summary, other exclusion criteria details may apply
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