The OPAL Study: AVM0703 for Treating Lymphoid Cancers

Sponsor: AVM Biotechnology Inc

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04329728

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, AVM0703, given as a single IV infusion to patients with lymphoid cancers. The study aims to find out how well the drug works and how the body processes it.

Patient Parameters

Program Overview

The OPAL Study is a clinical trial designed to test a new drug called AVM0703 for treating lymphoid cancers. The study is open-label, meaning both the researchers and participants know what treatment is being given. It is divided into two phases: Phase 1 focuses on understanding the safety and how the drug is processed in the body, while Phase 2 looks at how effective the drug is in treating the cancer. Participants will receive AVM0703 through an IV infusion, and researchers will monitor their response to the treatment.

Description

In Phase 2 of the study, patients will receive repeated doses of AVM0703 every 21 days until they experience side effects, the cancer progresses, or they can no longer tolerate the treatment. The goal is to determine how many doses are safe and effective. Researchers will conduct various tests to monitor how the drug is processed in the body and its effects on the cancer. A committee will review the data to decide if the treatment should continue or be adjusted.

Patients who cannot follow the 21-day dosing schedule may receive treatment according to a different plan. An 18 mg/kg dose has been approved, and a higher 21 mg/kg dose is being tested. Patients will receive additional medications to prevent side effects, such as hydrocortisone to prevent brain-related side effects and medications to protect the stomach and prevent tumor lysis syndrome (TLS), a condition that can occur when cancer cells break down rapidly.

The study includes patients with various types of lymphoid cancers, such as diffuse large B-cell lymphoma (DLBCL), Burkitt lymphoma, chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL). Up to 18 patients will be enrolled for each type of cancer.

If a patient's cancer returns, they may receive additional treatment with AVM0703. Patients will be followed for survival and any additional cancer treatments they receive will be recorded.

Eligibility Criteria

Inclusion Criteria

  • Age 12 years or older and weigh at least 40 kg.
  • Diagnosed with specific types of lymphoid cancers, such as DLBCL, high-grade B-cell lymphoma, or CLL.
  • Cancer must have returned or not responded to previous treatments.
  • Good overall health with a performance status score of 50 or higher.
  • Meet specific blood test criteria, including adequate blood cell counts and organ function.
  • Able to breathe well with good oxygen levels.
  • Women of childbearing age must have a negative pregnancy test and agree to use contraception.
  • Able to understand and sign a consent form, with parental consent for minors.

Exclusion Criteria

  • History of another cancer, except for certain skin cancers or cancers in remission for 2 years.
  • Significant heart disease or uncontrolled high blood pressure.
  • Abnormal heart rhythms or other heart conditions.
  • Stomach or intestinal ulcers.
  • Uncontrolled diabetes.
  • Allergies to the study drug or its ingredients.
  • Untreated infections, including hepatitis B or C, HIV, or tuberculosis.
  • Recent live vaccinations.
  • Pregnant or breastfeeding.
  • Participating in another clinical trial.
  • Uncontrolled mental health conditions, such as bipolar disorder or schizophrenia.

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