Study on Seclidemstat and Azacitidine for Treating Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04734990

Provider View

This clinical trial is testing the combination of two drugs, seclidemstat and azacitidine, to find the best dose and see if they can effectively treat myelodysplastic syndrome or chronic myelomonocytic leukemia by stopping cancer cell growth.

Patient Parameters

Program Overview

This study aims to find the best dose of seclidemstat when used with azacitidine to treat patients with myelodysplastic syndrome or chronic myelomonocytic leukemia. Seclidemstat may help stop cancer cells from growing by blocking certain enzymes, while azacitidine may prevent the formation of cancerous growths. The combination of these drugs could potentially kill more cancer cells.

Description

The main goals of this study are to determine the safety and best dose of seclidemstat when combined with azacitidine, and to see how well this combination works in treating the cancer. Researchers will also look at how long patients live without the cancer coming back and how the treatment affects different types of the disease.

In the first phase, different doses of seclidemstat will be tested to find the safest and most effective dose. In the second phase, this dose will be used to treat more patients to see how well it works.

Patients will receive azacitidine either through an IV or as an injection under the skin for the first seven days of each 28-day cycle. Seclidemstat will be taken by mouth once on the first day of the first cycle, then twice daily for the rest of the cycle and in all following cycles. The study will continue as long as the cancer does not progress and the treatment is tolerated well.

After finishing the treatment, patients will be monitored for 30 days and then every six months to check their health and any long-term effects.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older, as myelodysplastic syndrome is rare in children.
  • Diagnosed with myelodysplastic syndrome or chronic myelomonocytic leukemia, with specific risk factors or genetic mutations.
  • Cancer has not responded to previous treatments or has returned after treatment.
  • Normal kidney function or creatinine clearance of at least 50 ml/min.
  • Adequate liver function with specific limits on bilirubin and liver enzymes.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Must have signed an informed consent to participate in the study.
  • Previous use of certain medications for blood cell growth is allowed if deemed necessary.

Exclusion Criteria

  • Uncontrolled infections not responding to antibiotics.
  • Severe heart conditions or recent heart attack.
  • Long QT syndrome or family history of sudden death.
  • Use of certain medications that cannot be stopped before the study.
  • Pregnant or breastfeeding women.
  • Individuals not willing to use effective birth control during the study.
  • Positive pregnancy test for women of childbearing potential.
  • Participation in another clinical trial or receiving other cancer treatments.
  • Recent stem cell transplant or ongoing graft versus host disease.
  • Active hepatitis B or C infection, or history of HIV.

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