Study on NADUNOLIMAB with Azacitidine (With/Without Venetoclax) for Patients with Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML)

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT06548230

Provider View

This clinical trial is testing a new treatment using NADUNOLIMAB, combined with azacitidine and possibly venetoclax, to see if it is safe and effective for patients with high-risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML).

Patient Parameters

Program Overview

The aim of this study is to determine if NADUNOLIMAB, an antibody targeting leukemia stem cells, is safe and effective when used alone or with azacitidine and venetoclax. This treatment is for patients with high-risk Myelodysplastic Syndrome (MDS) and Acute Myelogenous Leukemia (AML). The study will help establish the best dose for future research and evaluate how well the treatment works in reducing cancer cells.

Description

This study is divided into two parts:

  • Primary Objectives:

    • To find the safest and most effective dose of NADUNOLIMAB when combined with azacitidine for patients with untreated or previously treated high-risk MDS (Arm 1).
    • To evaluate the combination of NADUNOLIMAB, azacitidine, and venetoclax for patients with relapsed or hard-to-treat AML (Arm 2).

  • Secondary Objectives:

    • To measure how many patients achieve complete or partial remission within six treatment cycles.
    • To assess the overall response rate in patients with high-risk MDS.
    • To determine how long the treatment response lasts.

  • Exploratory Objectives:

    • To study changes in blood markers and cancer cells.
    • To evaluate how the body processes the drug and its potential immune response.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with high-risk MDS or relapsed/refractory AML.
  • Aged 18 years or older.
  • Good overall health with a performance status of 0 to 2.
  • Temporary treatments like apheresis or limited chemotherapy are allowed before starting the study.
  • At least two weeks since the last treatment, or shorter if the drug clears the body faster.
  • Side effects from previous treatments should be mild or resolved.
  • No other cancer treatments allowed during the study, except for specific cases.
  • Adequate kidney and liver function.
  • White blood cell count below 10 x 10^9/L.
  • Ability to understand and sign consent forms.
  • Women must not be pregnant and must use contraception during and after the study.
  • Men must use contraception during and after the study.

Exclusion Criteria

  • Severe or uncontrolled medical conditions that could affect participation.
  • Receiving active treatment for another cancer.
  • Recent organ transplant or severe graft-versus-host disease.
  • Uncontrolled central nervous system leukemia.
  • Uncontrolled HIV or hepatitis infections.
  • Recent major surgery.
  • Other severe medical or psychiatric conditions.
  • Active infections or uncontrolled heart conditions.
  • Use of certain medications like anti-TNF drugs.
  • Inability to follow study procedures.
  • Recent live vaccinations.

Locations

FACILITYZIPCITYSTATE
MD Anderson Cancer Center77030HoustonTexas

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