IRB #

STUDY00017379

Title

Phase 1b, multi-arm, open-label study of PDR001 and/or MBG453 in combination with decitabine in patients with acute myeloid leukemia or high risk myelodysplastic syndrome

Principal Investigator

Uma Borate

Study Purpose

The purpose of this study is to identify a dose of PDR001 and/or MBG453 that can be safely given after decitabine and to learn if the combination/s can have possible benefits for people with Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS).

Medical Condition(s)

Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)

Eligibility Criteria

Eligible subjects must meet the following:
-Be at least 18 years or older,
-Have either been diagnosed with AML and your disease has been untreated or, after treatment, your disease has either relapsed (come back) or is refractory (has not responded to treatment) OR
-Have been diagnosed with high risk MDS

Age Range

18 - n/a

Healthy Volunteers Needed

No

Duration of Participation

You may receive the study drugs for up to 6 cycles. A cycle consists of 28 days. At the end of Cycle 6, you may continue to receive decitabine alone for an additional 3 cycles at your investigator’s discretion. After you finish receiving the study drugs, you will be contacted (by phone, email or letter) every month for safety follow-up for up to 150 days (approximately 5 months) after stopping the study drugs.

Minors Included

No

Contact

Clinical Trials Information Line
Phone: 503-494-1080
Email: trials@ohsu.edu

Sponsor

Novartis Pharmaceuticals Corporation

Recruitment End

12/31/2027

Compensation Provided

No


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