Guadecitabine and Atezolizumab in Treating Patients With Advanced Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia That Is Refractory or Relapsed

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Southern California
Study ID
NCT02935361
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic Syndrome
  • Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 2, 2016
Status verified
Jan 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
33 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (guadecitabine, atezolizumab)
    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.

Primary Outcome Measure

Incidence of dose-limiting toxicities evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: Up to 56 days ]

Locations (4)

FacilityCityStateZIPSite coordinators
USC / Norris Comprehensive Cancer CenterLos AngelesCalifornia90033-
University of Maryland Medical CenterBaltimoreMaryland21201-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Temple University HospitalPhiladelphiaPennsylvania19140-

Find similar trials in Los Angeles, CA

By research site
USC / Norris Comprehensive Cancer Center· Los Angeles, CAUniversity of Maryland Medical Center· Baltimore, MDFox Chase Cancer Center· Philadelphia, PATemple University Hospital· Philadelphia, PA

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