Study on AZD0486 as a Single Treatment for B-cell Acute Lymphoblastic Leukemia

Sponsor: AstraZeneca

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06137118

Provider View

This clinical trial is testing a new drug, AZD0486, to see if it is safe and effective for patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) who have not responded to at least two previous treatments.

Patient Parameters

Program Overview

This study is in its early stages and is being conducted at multiple locations around the world. It aims to find the best dose of AZD0486 and to see how well it works on its own in patients with B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or not responded to other treatments. The study has three parts: Part A will test different doses, Part B will optimize the dose, and Part C will expand the study to more patients at the best dose found.

Description

The trial is designed to evaluate the safety and effectiveness of AZD0486 when used alone in patients with relapsed or refractory B-cell Acute Lymphoblastic Leukemia (B-ALL). The study will look at how the drug is processed in the body and its effects on the disease. It will be conducted in three parts: Part A will involve increasing doses to find a safe level, Part B will refine the dose, and Part C will involve more patients to confirm the best dose.

Eligibility Criteria

Inclusion Criteria

  • Age 16 and older for Part A, and 12 and older for Parts B and C.
  • Diagnosed with B-cell Acute Lymphoblastic Leukemia (B-ALL) with CD19 marker.
  • Cancer has returned or not responded after at least two previous treatments, or after one treatment if no standard options are available.
  • Philadelphia chromosome-positive patients can join Part A if they cannot tolerate or do not respond to TKIs.
  • For those over 16, a performance status score of 2 or less; for those 16 or younger, a Lansky score of 50 or more.

Exclusion Criteria

  • Active cancer in the central nervous system (CNS), shown by cancer cells in the spinal fluid.
  • Cancer relapse only outside the bone marrow.
  • Testicular leukemia.
  • History of serious brain or nervous system conditions like epilepsy, stroke, or severe brain injuries.
  • Previous severe nervous system side effects from certain cancer treatments.
  • History of other cancers, with some exceptions.
  • Unresolved side effects from previous treatments that are moderate or worse.
  • Recent treatment with certain cancer therapies, including TCEs within 4 weeks, CAR T-cell therapy or autologous HSCT within 8 weeks, or alloSCT within 12 weeks.
  • Graft-versus-host disease (GVHD) needing immunosuppressive treatment within 3 weeks before starting AZD0486.

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