Study on LB-100 for Patients with Low or Intermediate-1 Risk Myelodysplastic Syndromes (MDS)

Sponsor: Lixte Biotechnology Holdings, Inc.

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03886662

Provider View

This clinical trial is testing the safety and effectiveness of a new drug, LB-100, for treating myelodysplastic syndromes (MDS). The study will be conducted in two phases to determine the best dose and evaluate the benefits of the treatment.

Patient Parameters

Program Overview

The purpose of this study is to test a new drug called LB-100 for treating myelodysplastic syndromes (MDS), a type of blood disorder. LB-100 will be given through an IV drip over two hours. The study has two parts: In the first part, different doses of LB-100 will be tested to find a safe dose. In the second part, the safe dose will be given to more patients to see how well it works and if it is safe.

Eligibility Criteria

Inclusion Criteria

  • Must sign a consent form and be able to follow study requirements.
  • Have good organ function based on specific blood tests:
    • Creatinine clearance (CrCl) of at least 60ml/min
    • Total serum bilirubin less than 1.5 times the normal limit, or up to 3 times the normal limit if certain conditions are met
    • Liver enzymes (AST and ALT) less than 3 times the normal limit
  • Be 18 years or older.
  • Have a confirmed diagnosis of MDS or MDS/myeloproliferative neoplasm (MPN) that needs treatment and meets specific risk criteria.
  • For patients without a specific genetic deletion (non-del(5q)), must have tried at least two cycles of certain treatments without success.
  • For patients with a specific genetic deletion (del(5q)), must have tried at least two cycles of lenalidomide without success.
  • Have a performance status score of 0, 1, or 2, indicating good overall health.
  • Women and men must agree to use effective birth control during the study.

Exclusion Criteria

  • Have a known history of HIV infection.
  • Have certain heart problems, such as:
    • Heart failure with symptoms
    • Recent heart attack (within 6 months)
    • Unstable chest pain
    • Serious uncontrolled heart rhythm issues
    • Specific heart rate measurement (QTcF) of 450 msec or more
  • Have other cancers or had cancer with less than a 1-year disease-free period, except for certain skin or cervical cancers.
  • Have used other cancer treatments within 14 days before starting the study drug.
  • Cannot use certain growth factors during the study, except in specific cases of infection.
  • Pregnant women cannot participate, and breastfeeding should be stopped if treated with LB-100.

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