US Study on UM171-Expanded Cord Blood Transplants for Patients with High-Risk Leukemia or Myelodysplasia

Sponsor: ExCellThera inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04103879

Provider View

This clinical trial is exploring a new method using UM171-expanded cord blood transplants to treat patients with high-risk leukemia or myelodysplasia who do not have a matching donor. The study aims to improve transplant outcomes by increasing cell counts and reducing complications.

Patient Parameters

Program Overview

Cord blood transplants are an option for patients who cannot find a matching donor, but they often face challenges like low cell counts and high risks during recovery. This study is testing a new approach using a molecule called UM171 to expand cord blood cells, which may help overcome these challenges. Previous research showed promising results, with faster recovery and lower risks of complications. This study will apply the same strategy to patients with high-risk acute leukemia or myelodysplasia to see if it can improve their outcomes.

Eligibility Criteria

Inclusion Criteria

  • Have a high-risk blood cancer, such as:
    • Acute Myeloid Leukemia (AML) that hasn't responded to treatment or has returned after a transplant.
    • Acute Lymphoid Leukemia (ALL) with similar conditions.
    • Myelodysplastic syndrome with specific risk factors or progression.
    • Chronic myelogenous leukemia that has progressed to a severe stage.
  • Have two cord blood units available that meet specific matching and cell count criteria.
  • Be in good enough health to participate, with a performance score of 70 or higher.
  • Have adequate heart and lung function.
  • Have acceptable liver and kidney function based on blood tests.
  • Meet specific health criteria if over 60 years old or if cancer is active in the bone marrow.

Exclusion Criteria

  • Have had a major transplant within the last 6 months.
  • Have an active or recent serious fungal infection.
  • Have another type of cancer with a poor long-term outlook.
  • Be HIV positive.
  • Have active hepatitis B or C infections.
  • Have liver cirrhosis.
  • Be pregnant, breastfeeding, or not willing to use birth control.
  • Have any condition that could affect the study's outcome.
  • Have active cancer in the central nervous system.
  • Have a specific type of tumor larger than 2 cm.

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