Study on Subcutaneous Blinatumomab for Treating Acute Lymphoblastic Leukemia (ALL)

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04521231

This clinical trial is testing a new way to give the drug blinatumomab under the skin to see if it is safe and effective for treating Acute Lymphoblastic Leukemia (ALL). The study will also find the best dose to use in future research.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of giving blinatumomab as an injection under the skin for patients with Acute Lymphoblastic Leukemia (ALL). Researchers aim to find the highest dose that can be given safely and the recommended dose for future studies. The study will also look at how the body processes two different formulations of the drug.

Eligibility Criteria

Inclusion Criteria

  • Age 18 years or older.
  • Diagnosed with B-precursor Acute Lymphoblastic Leukemia (ALL) that:
    • Did not respond to initial treatment or at least one additional treatment, OR
    • Has returned after being treated, whether it's the first, second, third, or later relapse.
  • More than 5% cancer cells in the bone marrow, unless the disease is only outside the bone marrow and not in the central nervous system.
  • Good overall health with a performance status score of 2 or less.
  • Patients with a specific type of ALL (B Cell ALL Ph+) who cannot tolerate or did not respond to previous treatments with tyrosine kinase inhibitors (TKIs) are eligible.

Exclusion Criteria

  • Active leukemia in the central nervous system (CNS) or signs of CNS leukemia.
  • History of serious brain or nervous system conditions, such as seizures, stroke, or severe brain injuries.
  • Disease only outside the bone marrow.
  • Active or uncontrolled infections or other conditions that could worsen with treatment.
  • Testicular leukemia.
  • History of other cancers (with some exceptions) within the last 3 years.
  • Recent stem cell transplant within 12 weeks before starting the study treatment.
  • Recent cancer treatment, including chemotherapy within 2 weeks or immunotherapy within 4 weeks before starting the study treatment.
  • Participation in another clinical trial within the last 30 days.
  • Abnormal lab test results at screening.
  • Women who are breastfeeding or plan to breastfeed during treatment and for 96 hours after the last dose.

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