Clinical Trials

Inclusion Criteria

• Diagnosis of new 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 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)