Guadecitabine + Atezolizumab for Chronic Myelomonocytic Leukemia

Recruiting in Palo Alto (17 mi)

+3 other locations

Casey L. O'Connell - Keck Medicine of USC

Overseen byCasey O'Connell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of Southern California

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of guadecitabine when given together with atezolizumab and to see how well they work in treating patients with myelodysplastic syndrome or chronic myelomonocytic leukemia that has spread to other places in the body and has come back or does not respond to treatment. Guadecitabine may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as atezolizumab, may interfere with the ability of cancer cells to grow and spread. Giving guadecitabine and atezolizumab may work better in treating patients with myelodysplastic syndrome or chronic myelomonocytic leukemia.

Eligibility Criteria

This trial is for adults with advanced Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML) that has returned or isn't responding to treatment. Participants must have tried specific drugs before, be able to follow the study plan, and not be pregnant or fathering a child. They should also meet certain health criteria like normal organ function tests.

Inclusion Criteria

Subject has signed and dated informed consent

I agree to not have unprotected sex or donate sperm.

Aspartate aminotransferase (ALT) and alanine aminotransferase (AST) =< 3 x ULN

+9 more

Exclusion Criteria

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I haven't had a serious infection needing strong medicine or a hospital stay in the last 28 days.

I have an autoimmune disease, but it's not vitiligo, type 1 diabetes, or hypothyroidism needing hormone therapy.

+15 more

Participant Groups

The trial is testing how well guadecitabine works with atezolizumab in treating MDS/CMML. Guadecitabine may block enzymes needed for cancer cell growth, while atezolizumab, an antibody, might stop cancer cells from growing and spreading.

1Treatment groups

Experimental Treatment

Group I: Treatment (guadecitabine, atezolizumab)Experimental Treatment2 Interventions

Patients receive guadecitabine SC on days 1-5 and atezolizumab IV over 30-60 minutes on days 8 and 22. Courses repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.

Atezolizumab is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Tecentriq for: