Study on AZD4512 Alone or with Other Cancer Drugs for Patients with Acute Lymphoblastic Leukemia

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07109219

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD4512, either by itself or combined with other cancer treatments, in patients with a type of blood cancer called acute lymphoblastic leukemia that has returned or not responded to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective the drug AZD4512 is for patients with relapsed or refractory B-Cell acute lymphoblastic leukemia (B-ALL). It will also look at how the body processes the drug and its effects on the cancer. The trial is open to patients who have not responded to previous treatments or whose cancer has returned.

Description

This study is divided into two parts and involves patients with relapsed or refractory B-Cell acute lymphoblastic leukemia (B-ALL). In the first part, researchers will test different doses of AZD4512 to find the safest and most effective amount. In the second part, they will optimize the dose based on the results from the first part. The study is open to adults and young adults aged 16 and older in the first part, and 12 and older in the second part. Participants will receive AZD4512 either alone or in combination with other cancer treatments, and their response to the treatment will be closely monitored.

Eligibility Criteria

Inclusion Criteria

  • Age 16 or older for Module 1, and 12 or older for Module 2.
  • Diagnosed with CD22-positive B-ALL, a type of blood cancer.
  • Cancer must have returned or not responded to previous treatments.
  • Must have tried at least two previous treatments, or one if no other standard options are available.
  • Must have a specific performance status score indicating they are well enough to participate.
  • Must have a low count of certain cancer cells in the blood.
  • Must have had certain previous treatments at least several weeks before starting the study.

Exclusion Criteria

  • Have Burkitt lymphoma or leukemia.
  • Have cancer that is only outside the bone marrow, or active cancer in the testicles or central nervous system.
  • Have unresolved side effects from previous treatments, except for certain stable conditions.
  • Have a history of lung inflammation caused by drugs that required treatment with steroids or oxygen.
  • Have received certain cancer treatments or medications within a specified time before starting the study.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site32224JacksonvilleFlorida
Research Site60611ChicagoIllinois
Research Site52242Iowa CityIowa
Research Site37203NashvilleTennessee
Research Site77030HoustonTexas

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