SPARK-ALL: Calaspargase Pegol for Adults with Acute Lymphoblastic Leukemia (ALL)

Sponsor: Institut de Recherches Internationales Servier

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04817761

Provider View

This clinical trial is testing the safety and effectiveness of a drug called Calaspargase Pegol in adults with a type of blood cancer known as Philadelphia-negative Acute Lymphoblastic Leukemia (ALL).

Patient Parameters

Program Overview

The study aims to confirm the best dose and evaluate the safety of Calaspargase Pegol for treating adults with Philadelphia-negative Acute Lymphoblastic Leukemia (ALL). It is divided into two parts: the first part will determine the appropriate dose, and the second part will involve more participants receiving the confirmed dose.

Description

The trial is conducted in two stages. In the first stage, researchers will determine the best dose of Calaspargase Pegol. In the second stage, more participants will receive this confirmed dose to further evaluate its safety and effects.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 22 to 54 years old with newly diagnosed Philadelphia-negative B-cell or T-cell Acute Lymphoblastic Leukemia (ALL).
  • Must have a performance status score of 0 to 2, indicating full activity or some restriction in strenuous activities.
  • No previous treatment for ALL, except for limited use of corticosteroids or hydroxyurea for up to 7 days, and one dose of a specific chemotherapy drug (intrathecal cytarabine) before joining the study.

Exclusion Criteria

  • Patients with Philadelphia chromosome positive ALL, Burkitt's leukemia, mixed lineage/mixed phenotype acute leukemia, or acute undifferentiated leukemia.
  • Patients with Down syndrome.
  • Patients with active Hepatitis B or C infections.
  • Patients who are HIV-positive.
  • History of pancreatitis not related to gallstones.
  • Severe liver problems, indicated by high bilirubin or liver enzyme levels.
  • History of a specific liver condition called hepatic veno-occlusive disease (VOD).
  • Age 55 years or older.
  • Body Mass Index (BMI) over 35.

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