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Complete title: Initial Cytoreductive Therapy for Myelodysplastic Syndrome prior to Allogeneic Hematopoietic Cell Transplantation (the ICT-HCT Study)
|Research Study Number||2661.00|
|Principal Investigator||Bart Scott, MD|
Research Study Description
Eligibility Criteria (must meet the following to participate in this study)
Genders Eligible for Study: Both
- 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; the attending may use metrics such as Treatment Related Mortality Score (TRM) or Karnofsky performance status, in addition to clinical values (age, platelet count, serum albumin, secondary or de novo disease, white blood cell count, peripheral blood blast percentage, and serum creatinine) to determine if a patient should be included
- 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
Other eligibility criteria may apply.
Exclusions (conditions that would prevent participation in this study)
- 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)
Other exclusion criteria may apply.
Hematologic Malignancies; Leukemia; Myelodysplastic and Myeloproliferative Syndromes (MDS and MPD)
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