Study on Surovatamig (AZD0486) and Rituximab for Untreated Follicular Lymphoma Patients

Sponsor: AstraZeneca

Sponsor score: 40

ClinicalTrials ID:NCT06549595

Provider View

This clinical trial is testing a new combination of drugs, Surovatamig (AZD0486) and Rituximab, to see if it is more effective and safe compared to standard treatments for patients with untreated Follicular Lymphoma.

Patient Parameters

Program Overview

The study aims to evaluate how well the combination of Surovatamig (AZD0486) and Rituximab works in treating patients with Follicular Lymphoma who have not received any prior treatment. It will compare this new combination to standard treatment options chosen by the doctor. The study is conducted in multiple centers around the world and involves two main parts: a safety run-in to determine the best dose, followed by a Phase III trial to assess the effectiveness of the treatment.

Description

This study is divided into two parts:

  1. Safety Run-in: This initial phase will test different doses of Surovatamig (AZD0486) combined with Rituximab to find the safest and most effective dose.

  2. Phase III: This phase will compare the best dose of Surovatamig (AZD0486) plus Rituximab to standard treatment options. Participants will be divided into three groups:

    • Group A: Receives Surovatamig plus Rituximab following Schedule A.
    • Group B: Receives Surovatamig plus Rituximab following Schedule B.
    • Group C (Comparison Group): Receives one of the standard treatments chosen by the doctor, which may include R-CVP, R-CHOP, or B-R, all with Rituximab maintenance.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of classic Follicular Lymphoma.
  • Be in good overall health with an ECOG performance status of 0 to 2.
  • Have not received any previous treatment for lymphoma.
  • Require treatment based on specific medical criteria.
  • Have a type of cancer that can be measured and is visible on scans.
  • Be in stage II to IV of the disease and meet certain risk factors.
  • Have adequate liver, blood, kidney, and heart function.

Exclusion Criteria

  • Have a type of lymphoma that is more aggressive or has transformed into a high-grade form.
  • Cannot safely receive standard treatments like BR, RCVP, or R-CHOP.
  • Have or had lymphoma affecting the brain or spinal cord.
  • Have a serious brain condition that required treatment in the past year or is currently causing symptoms.
  • Have more than 5000 lymphoma cells circulating in the blood.
  • Have an active or uncontrolled infection that requires treatment, including recent COVID-19 infection.
  • Have a history of certain immune system disorders like HLH/MAS.

Locations

FACILITYZIPCITYSTATE
Research Site35805HuntsvilleAlabama
Research Site99508AnchorageAlaska
Research Site85054PhoenixArizona
Research Site93611ClovisCalifornia
Research Site90720Los AlamitosCalifornia
Research Site92121San DiegoCalifornia
Research Site90404Santa MonicaCalifornia
Research Site80045AuroraColorado
Research Site06510New HavenConnecticut
Research Site19713NewarkDelaware

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.