Chemotherapy in Treating Patients With Myelodysplastic Syndrome Before Donor Stem Cell Transplant
Condition: Chronic Myelomonocytic Leukemia; de Novo Myelodysplastic Syndrome; Myelodysplastic Syndrome; Secondary Myelodysplastic Syndrome
MeSH terms: Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Intervention: Azacitidine (AZC); Decitabine; Quality-of-Life Assessment
Intervention description: Given IV or SC; Given IV or SC; Ancillary studies
Intervention MeSH terms: Azacitidine; Decitabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: myelodysplastic syndrome; chronic myelomonocytic leukemia; bone marrow transplant; hypomethylating agent; induction chemotherapy

Summary:

      This randomized clinical trial studies different chemotherapies in treating patients with
      myelodysplastic syndrome before donor stem cell transplant. Giving chemotherapy before a
      donor stem cell transplant helps stop the growth of cancer cells in the bone marrow,
      including normal blood-forming cells (stem cells) and cancer cells, and may prevent the
      myelodysplastic syndrome from coming back after the transplant. When the healthy stem cells
      from a donor are infused into the patient they may help the patient's bone marrow make stem
      cells, red blood cells, white blood cells, and platelets.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of de novo or secondary myelodysplastic syndrome (MDS), including chronic
             myelomonocytic leukemia, as defined by the 2008 World Health Organization
             classification system

          -  Patients must have measurable disease requiring cytoreduction, defined as a bone
             marrow myeloblast count >= 5% and < 20% on morphologic examination or by flow
             cytometry in cases in which adequate morphologic examination is not possible

          -  Patients must be considered to have an acceptable risk of early mortality with
             intensive chemotherapy as determined by the attending physician at the time of the
             initial visit; since the specific therapy within each arm will be determined after
             randomization, there is no threshold of organ dysfunction or performance status for
             inclusion

          -  Considered a potential transplant candidate; the attending/treating physician will
             determine transplant candidacy at the time of consent

          -  Capable of understanding the investigational nature, potential risks and benefits of
             the study, and able to provide valid informed consent

        Exclusion Criteria:

          -  A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health
             Organization classification system

          -  Previous treatment for MDS or acute myeloblastic leukemia (AML) with intensive
             chemotherapy regimen (induction chemotherapy) or hypomethylating agent

          -  Have any other severe concurrent disease, or have a history of serious organ
             dysfunction or disease involving the heart, kidney, liver, or other organ system that
             may place the patient at undue risk to undergo treatment

          -  Patients with a systemic fungal, bacterial, viral, or other infection not controlled
             (defined as exhibiting ongoing signs/symptoms related to the infection and without
             improvement, despite appropriate antibiotics or other treatment)

          -  Females who are pregnant or breastfeeding

          -  Fertile men and women unwilling to use contraceptive techniques during and for 12
             months following treatment

          -  Any uncontrolled or significant concurrent disease, illness, or psychiatric disorder
             that would compromise patient safety or compliance, interfere with consent, study
             participation, follow up, or interpretation of study results

          -  Clinical evidence suggestive of central nervous system (CNS) involvement with MDS
             unless a lumbar puncture confirms the absence of leukemic blasts in the cerebrospinal
             fluid (CSF)