Azacitidine in Treating Patients With Relapsed Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia, or Acute Myeloid Leukemia Who Have Undergone Stem Cell Transplant
Condition: Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(15;17)(q22;q12); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Childhood Myelodysplastic Syndromes; Chronic Myelomonocytic Leukemia; Previously Treated Myelodysplastic Syndromes; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Myelodysplastic Syndromes
MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Leukemia, Myelomonocytic, Acute; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome; Recurrence
Intervention: azacitidine; laboratory biomarker analysis
Intervention description: Given SC or IV; Correlative studies
Intervention MeSH terms: Azacitidine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Healthy volunteers: No

Summary:

      This phase II trial studies how well azacitidine works in treating patients with relapsed
      myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), or acute myeloid
      leukemia (AML) who have undergone stem cell transplant. Drugs used in chemotherapy, such as
      azacitidine, work in different ways to stop the growth of cancer cells, either by killing the
      cells or by stopping them from dividing.
    

Eligibility criteria:

        Inclusion Criteria:

          -  MDS, CMML or AML patients (as diagnosed by World Health Organization [WHO] criteria)
             with evidence of relapse or progression at >= day 28 and < day 100 post-transplant

          -  Recurrent or increased cytogenetic abnormalities by standard karyotype or fluorescence
             in situ hybridization (FISH) (the cytogenetic abnormalities must have been previously
             documented at some time point between diagnosis and date of stem cell transplant)

          -  Morphologic evidence of recurrence or increased abnormal myeloblasts in peripheral
             blood or marrow

          -  Flow Cytometric evidence of disease as determined by recurrent or increased abnormal
             myeloblasts in peripheral blood or marrow

          -  Extramedullary relapse (local radiotherapy will be allowed)

          -  MDS, CMML, or AML patients with persistent stable disease or persistent disease with
             regression at >= day 28 and < day 100 post-transplant; the inclusion of patients with
             persistent stable or persistent regressing disease in this protocol is not meant to
             advocate treatment; however, if the attending physician is inclined to offer treatment
             then these patients would be eligible for this study

          -  Persistence of cytogenetic abnormalities by standard karyotype or FISH

          -  Persistent morphologic evidence of abnormal myeloblasts (in patients with CMML the
             monoblastoid population is included) in peripheral blood or marrow

          -  Persistent flow cytometric evidence of abnormal myeloblasts (in patients with CMML the
             monoblastoid population is included) in peripheral blood or marrow

          -  Extramedullary persistence or regression

        Exclusion Criteria:

          -  Refractory disease at time of stem cell transplant; patients who received chemotherapy
             prior to transplant with no evidence of response by International Working Group (IWG)
             criteria

          -  >= 10% bone marrow myeloblasts as measured by morphology

          -  Evidence of central nervous system (CNS) disease at time of relapse by morphology or
             flow (a diagnostic lumbar puncture [LP] is not required at time of relapse)

          -  Serum creatinine > 2 x ULN (upper limit of normal)

          -  Aspartate aminotransferase (AST)/ alanine aminotransferase (ALT) > 2x ULN

          -  Performance status > 2 (Eastern Cooperative Oncology Group [ECOG] Scale)

          -  Patients with severe disease other than MDS, CMML or AML which would be expected to
             prevent compliance with treatment

          -  Patients with severe infections (pneumonia, sepsis, etc) within the 2 weeks prior to
             the anticipated start of protocol treatment