Study on Guadecitabine and Atezolizumab for Treating Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Sponsor: University of Southern California
ClinicalTrials ID:NCT02935361
This clinical trial is testing a combination of two drugs, guadecitabine and atezolizumab, to see if they can help treat patients with advanced myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has returned or not responded to previous treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if the combination of guadecitabine and atezolizumab is safe and effective for treating patients with advanced myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) that has either come back or not responded to previous treatments. Guadecitabine may help stop cancer cells from growing by blocking certain enzymes, while atezolizumab, a type of monoclonal antibody, may help prevent cancer cells from growing and spreading. The study will determine the best dose of guadecitabine when used with atezolizumab and evaluate how well this combination works in treating these conditions.
Description
The study is divided into two phases. In Phase I, researchers will determine a safe dose of guadecitabine when combined with atezolizumab and assess the safety of this combination in patients with myelodysplastic syndrome (MDS) who have not responded to or have relapsed after treatment with other drugs. In Phase II, the effectiveness of the combination will be evaluated in patients with newly diagnosed MDS.
The study will also look at how the combination affects overall survival, the duration of response, and the need for blood transfusions in patients with relapsed or newly diagnosed MDS. Researchers will also study specific proteins and immune cells in the blood and bone marrow to understand how the treatment works.
Participants will receive guadecitabine as an injection under the skin for five days and atezolizumab through an IV on specific days. This cycle will repeat every 28 days for up to 24 months, as long as the disease does not progress and side effects are manageable. After completing the treatment, patients will be monitored for up to 90 days and then every six months.
Eligibility Criteria
Inclusion Criteria
- Adults with advanced myelodysplastic syndrome (MDS) who have previously been treated with azacitidine or decitabine and did not respond or relapsed.
- MDS classified as intermediate or higher risk, or chronic myelomonocytic leukemia (CMML).
- Must have a bone marrow examination within 8 weeks before joining the study.
- Must be able to understand and follow study instructions and have signed informed consent.
- Must have certain blood test results within normal limits.
- Women of childbearing potential must agree to use effective birth control during the study and for 90 days after the last dose of atezolizumab.
- Men must agree to use effective birth control and not donate sperm during the study and for 120 days after the last dose of guadecitabine.
Exclusion Criteria
- History of autoimmune diseases, except for certain conditions like vitiligo or type 1 diabetes.
- History of lung diseases like interstitial lung disease or pneumonitis.
- Currently receiving other cancer treatments.
- History of allergic reactions to similar drugs.
- Diagnosis of acute myeloid leukemia (AML) not transformed from MDS.
- Short life expectancy due to other health conditions.
- Pregnant or nursing women.
- Current alcohol or drug abuse.
- Recent treatment with investigational drugs or certain medications.
- Uncontrolled infections or other serious health conditions.
- Infected with hepatitis B, C, or HIV unless on stable treatment.
- History of severe allergic reactions to certain antibodies or proteins.
- Previous bone marrow or organ transplants.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| USC / Norris Comprehensive Cancer Center | 90033 | Los Angeles | California |
| University of Maryland Medical Center | 21201 | Baltimore | Maryland |
| Fox Chase Cancer Center | 19111 | Philadelphia | Pennsylvania |
| Temple University Hospital | 19140 | Philadelphia | Pennsylvania |
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