Busulfan/Clofarabine + Allogeneic Stem Cell Transplantation
Condition: Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Myelodysplastic Syndrome
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Intervention: Busulfan; Clofarabine; Allogeneic Stem Cell Infusion
Intervention description: Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation; Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation; Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy
Intervention MeSH terms: Busulfan; Clofarabine
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This research is a phase II clinical trial. Phase II clinical trials test the effectiveness
      of an investigational intervention to learn whether it works in treating a specific cancer.
      "Investigational" means that the study intervention is still being studied and that research
      doctors are trying to find out more about it. It also means that the FDA has not yet approved
      this study intervention for your type of cancer.

      All participants on this study are treated in an identical manner. The investigators are
      doing this study because there continues to be a significant risk of relapse of disease after
      reduced intensity transplantation. In studies which have compared transplants using
      high-doses of chemotherapy and/or radiation versus reduced intensity transplants, patients
      undergoing reduced intensity transplants appear to have higher rates of relapse, but lower
      rates of toxicity and complication. This study attempts to utilize clofarabine, a newer
      chemotherapy agent shown to be quite active in AML, ALL, and MDS, to increase the anti-tumor
      effects of the conditioning regimen without accumulating unacceptable toxicity.

      The reduced intensity allogeneic stem cell transplantation procedure involves giving you
      chemotherapy in relatively less intense doses to suppress your immune system. This is
      followed by an infusion of healthy blood stem cells from a matched related donor or a matched
      unrelated volunteer donor. It is hoped that these donor cells can eventually then attack any
      cancer cells which remain.

      In this research study, the investigators are looking to see how well this new combination of
      busulfan and clofarabine works in reduced intensity allogeneic stem cell transplantation. By
      "works" the investigators mean to analyze safety, ability of donor cells to engraft (take
      hold), as well as measures of complications including toxicity, infections, graft-vs-host
      disease (GVHD), and relapse.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Must have well-matched adult donor willing to donate peripheral blood stem cells with
             well-matched defined as 8/8 matched related or unrelated donor

          -  Adequate organ functioning

        Exclusion Criteria:

          -  Pregnant or breastfeeding

          -  Psychiatric disease severely impairing the compliance of the patient to participate in
             the study and/or give informed consent

          -  Evidence of prior exposure to HIV or HCV