TINI 2: Total Therapy for Infants with Acute Lymphoblastic Leukemia II

Sponsor: Tanja Andrea Gruber

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05848687

Provider View

This study aims to improve treatment for infants with acute lymphoblastic leukemia (ALL) by testing an immunotherapy drug called blinatumomab, which targets leukemia cells.

Patient Parameters

Program Overview

The goal of this study is to enhance the treatment used in the previous TINI study for infants with acute lymphoblastic leukemia (ALL). Researchers will test the effectiveness of an immunotherapy drug called blinatumomab, which works by targeting a specific marker, CD19, found on the surface of leukemia cells. This study aims to see if blinatumomab can help clear persistent leukemia in young patients.

Eligibility Criteria

Inclusion Criteria

  • Infants who are 365 days old or younger at the time of diagnosis.
  • Newly diagnosed with CD19 positive acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with 25% or more leukemia cells in the bone marrow, with or without disease outside the bone marrow.
  • Patients with CD19 positive biphenotypic acute leukemia or mature B-cell ALL with a specific genetic marker (KMT2Ar) are eligible.
  • Limited prior treatment, including short-term use of certain medications like hydroxyurea, glucocorticoids, cytarabine, vincristine, and one dose of intrathecal chemotherapy.
  • Written informed consent from a legal guardian or representative, following specific guidelines.

Exclusion Criteria

  • Patients who have received treatments not specified in the inclusion criteria.
  • Patients with mature B-cell ALL without the KMT2Ar marker, or those with acute myelogenous leukemia (AML) or T-cell ALL.
  • Patients with Down syndrome.
  • Legal guardian or representative unable or unwilling to provide written informed consent.

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