Study on Subcutaneous Blinatumomab for Treating Adults with CD19-Positive Mixed Phenotype Acute Leukemia (MPAL)

Sponsor: West Virginia University

Sponsor score: 0

ClinicalTrials ID:NCT07222579

Provider View

This clinical trial is testing a new way to give the drug blinatumomab under the skin to treat adults with a specific type of leukemia called CD19-positive Mixed Phenotype Acute Leukemia (MPAL). The study includes three groups of patients based on their condition and previous treatments.

Patient Parameters

Program Overview

This study is exploring the use of blinatumomab, a medication given under the skin, to treat adults with CD19-positive Mixed Phenotype Acute Leukemia (MPAL). The trial includes three groups of patients:

  1. Newly diagnosed patients who are 75 years or older or have other health issues that prevent them from receiving intensive chemotherapy.
  2. Patients who have achieved remission but still have detectable cancer cells.
  3. Patients whose cancer has returned or not responded to previous treatments. The main goals are to see how well the treatment works in each group. Participants will undergo various medical tests and procedures throughout the study, which includes a screening period, treatment period, and follow-up visits.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of MPAL based on specific medical criteria.
  • If previously received a stem cell transplant, must be at least 4 weeks post-transplant and not have severe graft-versus-host disease.
  • If leukemia has affected the central nervous system, it must be stable and not causing new symptoms.
  • Must understand and agree to the study requirements and sign a consent form.
  • Must be willing to attend all required study visits.

Specific Criteria for Cohort A:

  • Must be 75 years or older or have health conditions that prevent intensive chemotherapy, such as heart issues or poor lung function.

Specific Criteria for Cohort B:

  • Must have achieved remission but still have detectable cancer cells after previous treatment.
  • Must have good organ function and a performance status of 2 or less.

Specific Criteria for Cohort C:

  • Must have relapsed or refractory CD19+ MPAL.
  • Must have completed previous chemotherapy and recovered from its side effects.
  • Must have good organ function and a performance status of 2 or less.

Exclusion Criteria

  • Cannot be receiving other experimental treatments or cancer therapies, except for certain medications like corticosteroids or hydroxyurea.
  • Cannot have an active, uncontrolled infection, but infections under control with treatment are allowed.

Locations

FACILITYZIPCITYSTATE
West Virginia University Cancer Institute26506MorgantownWest Virginia

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