Pembrolizumab and Decitabine for Refractory or Relapsed Acute Myeloid Leukemia
Condition: Relapsed Acute Myeloid Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Background:

      Acute myeloid leukemia (AML) is a cancer of the white blood cells. It is fatal if not
      treated. Treatment for AML that has not responded to treatment (refractory) or has returned
      after treatment (relapsed) often do not work. Researchers want to see if an immunotherapy
      drug, combined with a less intense chemotherapy, may be able to help.

      Objective:

      To test if pembrolizumab, in combination with decitabine, is a possible treatment for people
      with relapsed or refractory AML.

      Eligibility:

      Adults 18 years of age and older with refractory AML or relapsed AML.

      Design:

      Participants will be first screened for eligibility.

      The study is counted in 21-day cycles. The initial phase of the study consists of 8 cycles.
      Participants may be in the study for up to 2 years if they are responding to the treatment.

      The first 3 weeks of treatment is usually done in the hospital. The rest may be done as an
      outpatient.

      Participants will get pembrolizumab at the beginning of each cycle through an IV.

      Participants will usually get decitabine by IV on days 8 12 and days 15 19 of every other
      cycle.

      Participants will give blood samples.

      Participants will have bone marrow exams. A needle will be inserted into the hip to extract
      cells from the bone marrow.

      Some participants may give a sample of saliva from the inside of their cheek.

      Some participants may give a small skin sample. The top layer of the skin is removed.

      Some patients may require leukapheresis before starting treatment. This is a procedure to
      remove leukemia cells in the blood stream.
    

Detailed description: 
      This is a pilot study to determine the feasibility of a novel combination of Pembrolizumab
      and Decitabine in relapsed/refractory adult AML patients. While both Pembrolizumab and
      Decitabine are FDA approved agents, this study will explore giving these drugs in combination
      for this population of patients.
    

Intervention name(s): Pembrolizumab; Decitabine
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).; Will be administered at a dose of 20 mg/m^2 by continuous intravenous infusion over 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7). Decitabine should be repeated every 6 weeks.
Other intervention name(s): Keytruda; MK-3475; Dacogen
Intervention MeSH terms: Pembrolizumab; Decitabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pembrolizumab; Decitabine; AML (Acute Myelogenous Leukemia)