Study on AZD4512 Alone or with Other Cancer Drugs for Treating Relapsed or Hard-to-Treat B-cell Non-Hodgkin Lymphoma

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT07123454

This clinical trial is testing the safety and effectiveness of a new drug, AZD4512, either by itself or combined with other cancer treatments, for patients with B-cell Non-Hodgkin Lymphoma that has returned or is not responding to previous treatments.

Patient Parameters

Program Overview

The study aims to evaluate how safe and effective AZD4512 is when used alone or with other cancer drugs in patients with B-cell Non-Hodgkin Lymphoma (B-NHL) that has come back or is not responding to treatment. The trial will start by testing AZD4512 alone in patients who have already tried at least two other treatments. Future parts of the study may include testing AZD4512 with other drugs for specific types of B-NHL.

Description

This study, called Lumi-NHL, is designed to test the safety and effectiveness of AZD4512, a new drug, either on its own or with other cancer treatments, in patients with B-cell Non-Hodgkin Lymphoma (B-NHL) that has returned or is not responding to previous treatments. The first part of the study will focus on using AZD4512 alone in patients who have already tried at least two other treatments. In the future, the study may expand to include testing AZD4512 with other drugs for specific types of B-NHL.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of B-cell Non-Hodgkin Lymphoma (B-NHL) according to the World Health Organization (WHO) 2021 classification.
  • In the initial phase, any B-NHL subtype is allowed, except for some specific types. In later phases, only certain subtypes like large B-cell lymphomas, mantle cell lymphoma, and follicular lymphoma grades 1-3a are included.
  • Must have B-NHL that has returned or is not responding after at least two previous treatments and have no other standard treatment options that improve survival.
  • Must have measurable disease according to specific medical criteria.
  • Must be in relatively good health with an ECOG performance status of 2 or less.
  • Must have adequate organ and bone marrow function as determined by specific medical tests.

Exclusion Criteria

  • Cannot have certain types of B-NHL, such as post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)/Small lymphocytic lymphoma (SLL).
  • Cannot have active involvement of the central nervous system (CNS) by B-NHL.
  • Cannot have received certain therapies like CAR-T or T cell engager therapies within 90 days before starting the study.
  • Cannot have received any investigational drug or other systemic cancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives before starting the study.
  • Cannot have had major surgery within 28 days before starting the study.
  • Cannot be using certain medications that affect the heart or liver at the start of the study.
  • Cannot have had other cancers within the last two years, except for certain non-threatening types.
  • Cannot have unresolved side effects from previous treatments, serious uncontrolled medical conditions, or active infections within 14 days before starting the study.
  • Cannot have a history or suspicion of significant lung disease.
  • Women who are pregnant or breastfeeding are not eligible.

Locations

FACILITYZIPCITYSTATE
Research Site91010DuarteCalifornia
Research Site32224JacksonvilleFlorida
Research Site55905RochesterMinnesota
Research Site10021New YorkNew York
Research Site44195ClevelandOhio
Research Site37203NashvilleTennessee

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