Study on AZD0486 Alone or with Other Cancer Drugs for Treating Mature B-Cell Blood Cancers

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06564038

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AZD0486, used alone or with other cancer treatments in patients with certain types of blood cancers.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective AZD0486 is when given by itself or with other cancer drugs to patients with mature B-cell blood cancers. It includes three substudies focusing on different types of these cancers: Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL), Mantle Cell Lymphoma (MCL), and Large B-Cell Lymphoma (LBCL) or other B-Cell Non-Hodgkin Lymphomas (B-NHL). The study involves a screening period, a treatment period, and a follow-up period.

Description

This open-label, multi-center study is designed to test the safety and initial effectiveness of AZD0486, either alone or combined with other cancer drugs, in patients with mature B-cell blood cancers. The study is divided into three substudies, each focusing on a specific type of cancer:

  • Substudy 1: For patients with Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Leukemia (SLL) that has returned or not responded to treatment.
  • Substudy 2: For patients with Mantle Cell Lymphoma (MCL) that has returned or not responded to treatment.
  • Substudy 3: For patients with Large B-Cell Lymphoma (LBCL) or other B-Cell Non-Hodgkin Lymphomas (B-NHL) that have returned or not responded to treatment.

The study will proceed through several stages, starting with a 28-day screening period to determine eligibility, followed by the treatment phase, and concluding with a follow-up period to monitor patient outcomes.

Eligibility Criteria

Inclusion Criteria

  • General Criteria for All Substudies:

    • Good overall health with an ECOG performance status of 0 to 2.
    • Use of contraception during treatment and for at least 6 months after the last dose.
    • Confirmed presence of CD19 if previously treated with anti-CD19 therapy.

  • Substudy 1 (CLL/SLL) Specific Criteria:

    • Need for treatment based on specific CLL guidelines.
    • At least one measurable tumor site.
    • Low lymphocyte count.
    • For Cohort 1A: At least two previous treatments, including specific inhibitors.
    • For Cohort 1B: At least one previous treatment and sensitivity to specific inhibitors.

  • Substudy 2 (MCL) Specific Criteria:

    • Diagnosis of MCL.
    • Advanced stage of cancer.
    • At least one measurable tumor site.
    • Low lymphocyte count.
    • For Cohort 2A: Cancer returned after two or more treatments, including specific inhibitors.
    • For Cohort 2B: Cancer returned after one or more treatments, not including specific inhibitors.

  • Substudy 3 (LBCL/B-NHL) Specific Criteria:

    • Diagnosis of Large B-Cell Lymphoma.
    • Cancer returned after at least one treatment.
    • Specific prognostic score.
    • At least one measurable tumor site.
    • Good heart function.
    • Use of contraception for at least 12 months after certain treatments or 6 months after AZD0486.

Exclusion Criteria

  • General Criteria for All Substudies:

    • Cancer in the central nervous system.
    • Recent surgery.
    • Significant heart disease.
    • Unresolved severe side effects from previous cancer treatments.
    • Recent cancer treatments or radiation.
    • Recent stem cell transplant or specific cell therapies.
    • Severe immune reactions from previous treatments.

  • Substudy 1 (CLL/SLL) Specific Criteria:

    • Transformation to a more aggressive cancer.
    • For Cohort 1B: Blood clotting disorders, certain drug interactions, recent brain bleeding or stroke, digestive issues, or use of certain blood thinners.

  • Substudy 2 (MCL) Specific Criteria:

    • For Cohort 2B: Blood clotting disorders, certain drug interactions, recent brain bleeding or stroke, digestive issues, or use of certain blood thinners.

  • Substudy 3 (LBCL/B-NHL) Specific Criteria:

    • Certain types of lymphoma or transformations.
    • High cumulative dose of specific chemotherapy drugs.

Locations

FACILITYZIPCITYSTATE
Research Site02215BostonMassachusetts
Research Site08901New BrunswickNew Jersey
Research Site10029New YorkNew York
Research Site28204CharlotteNorth Carolina
Research Site97239PortlandOregon
Research Site19104PhiladelphiaPennsylvania
Research Site02903ProvidenceRhode Island

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