Study on Navitoclax for Patients with Aggressive Myelodysplastic Syndrome After Standard Treatments Have Failed
Sponsor: Thomas Jefferson University
ClinicalTrials ID:NCT05564650
This clinical trial is testing a new treatment using navitoclax, venetoclax, and decitabine for patients with aggressive myelodysplastic syndrome (MDS) that has not responded to or has returned after standard treatments. The study aims to find the best dose, assess safety, and evaluate the effectiveness of this combination therapy.
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Program Overview
This study is exploring a new treatment for patients with aggressive myelodysplastic syndrome (MDS) that has either not responded to initial treatments or has come back. The trial will test the safety and side effects of a combination of three drugs: navitoclax, venetoclax, and decitabine. Navitoclax and venetoclax are oral medications that help kill cancer cells by blocking certain proteins that allow them to survive. Decitabine is given through an IV and works by interfering with DNA processes that control cell growth. The study will also look at how well this treatment works and its impact on patients' quality of life.
Description
The study is divided into two phases. In Phase I, researchers will determine the safest dose of navitoclax when combined with venetoclax and decitabine. In Phase II, they will evaluate how effective this combination is for patients whose MDS has returned or not responded to previous treatments.
During the first cycle of treatment, patients will take navitoclax by mouth once a day from days 3 to 16, venetoclax by mouth once a day from days 1 to 16, and receive decitabine through an IV from days 3 to 7. This cycle lasts 30 days unless the disease progresses or side effects become too severe. Patients will have bone marrow biopsies and blood samples taken at various points to monitor their response.
In subsequent cycles, patients will take navitoclax and venetoclax by mouth once a day from days 1 to 14, and receive decitabine through an IV from days 1 to 5. These cycles repeat every 28 days. If patients show improvement after six cycles, they may continue treatment. Bone marrow biopsies and blood samples will continue to be collected to assess progress.
After completing the study treatment, patients will be followed up every three months for a year, and survival will be monitored for two years from the last patient's enrollment.
Eligibility Criteria
Inclusion Criteria
- Must provide signed consent and agree to follow study procedures.
- Must be 18 years or older.
- Must have aggressive myelodysplastic syndrome (MDS) that has been treated with azacitidine or decitabine and venetoclax.
- Previous stem cell transplant is allowed if it was at least 90 days ago and no immunosuppressive drugs are being taken.
- Must have a performance status score of 0 to 2, indicating good overall health.
- Must be able to swallow pills.
- Must have adequate kidney and liver function as shown by specific blood tests.
- Women must not be pregnant or breastfeeding and must agree to use effective birth control during and after treatment.
- Men must agree to use effective birth control during and after treatment.
Exclusion Criteria
- Have an active, uncontrolled infection.
- Have uncontrolled HIV, hepatitis B, or hepatitis C infections.
- Have had another active cancer within the past two years, except for certain skin cancers or cervical cancer.
- Require medications that affect blood clotting, except for low-dose aspirin or certain blood thinners.
- Have a high white blood cell count that cannot be controlled.
- Have a condition that prevents taking medication by mouth.
- Are pregnant, breastfeeding, or planning to become pregnant during the study.
- Have known allergies to the study drugs.
- Have taken another investigational drug within two weeks before starting the study.
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