Study Comparing Blinatumomab with Low-intensity Chemotherapy Versus Standard Chemotherapy for Older Adults with Newly Diagnosed Philadelphia-negative B-cell Precursor Acute Lymphoblastic Leukemia

Sponsor: Amgen

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04994717

Provider View

This clinical trial is testing whether a new treatment approach using blinatumomab with low-intensity chemotherapy is safer and more effective than the standard chemotherapy for older adults with a specific type of leukemia.

Patient Parameters

Program Overview

The study aims to find out if using blinatumomab, a type of immunotherapy, along with low-intensity chemotherapy is safe and can help patients live longer without the leukemia coming back, compared to the usual chemotherapy treatment. The trial is for older adults who have been newly diagnosed with a type of leukemia called Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL).

Eligibility Criteria

Inclusion Criteria

  • Age 55 or older, or age 40 to 54 with certain health conditions like severe pancreatitis, diabetes with organ damage, severe liver disease, or a high body mass index with other health issues.
  • Newly diagnosed with Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL).
  • Able to perform daily activities with some limitations due to leukemia.
  • Have good organ function, including:
    • Kidney function with a filtration rate of at least 50 mL/min/1.73 m².
    • Liver function with total bilirubin levels within twice the normal limit, unless affected by specific conditions.
    • Heart function with a left ventricular ejection fraction of at least 50%.

Exclusion Criteria

  • Active leukemia in the central nervous system that hasn't been treated.
  • Serious brain conditions needing treatment, like unstable epilepsy.
  • Current or past autoimmune diseases that could affect the brain.
  • Known infections with HIV, active hepatitis B, or hepatitis C.
  • Signs of an acute or uncontrolled chronic infection.
  • Previous chemotherapy for the newly diagnosed leukemia, except for specific pre-treatment therapies or radiation for pain or stabilization.

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