Haploidentical Stem Cell Transplantation Using Post-Transplant Cyclophosphamide
Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome
About this trial
This is an interventional prevention trial for Acute Myeloid Leukemia focused on measuring NHL, Non-Hodgkin Lymphoma, Haploidentical, Bone Marrow Transplant, Stem Cell Transplant, Acute Myeloid Leukemia, Acute Lymphocytic Leukemia, Myelodysplastic Syndrome, Chronic Lymphocytic Leukemia, GVHD
Eligibility Criteria
Inclusion Criteria:
- Ages 16 years old and up
- Performance Status 70 percent or above
- Patients should have the following diseases:
- Acute myelogenous leukemia (AML)
- Acute lymphocytic leukemia or lymphoblastic lymphoma (ALL)
- Transfusion dependent myelodysplastic syndrome (MDS)
- Non-Hodgkin's Lymphoma (NHL)
- Chronic lymphocytic leukemia (CLL)
- Pulmonary function as measured by forced expiratory volume at one second (FEV1) and/or corrected diffusing capacity of lung for carbon monoxide (DLCO) at 60 percent of predicted or above
- Left ventricular ejection fraction at 45 percent or above
- If the donor-specific HLA antibodies (DSA) are positive, the patient must undergo a desensitization protocol resulting in undetectable DSA prior to day of transplant
Exclusion Criteria:
- Less than twenty-one days have elapsed since the subject's last radiation or chemotherapy prior to conditioning (except for hydroxyurea)
- Uncontrolled bacterial, fungal or viral infections at time of study enrollment
- Positive for HIV, human T-cell leukemia virus (HTLV-1) and/or Hepatitis C
- Subjects with signs/symptoms of active central nervous system (CNS) disease
Sites / Locations
- Loyola University Medical CenterRecruiting
Arms of the Study
Arm 1
Experimental
All patients will receive Haploidentical
The choice of the chemotherapy treatment for transplantation will be up to the investigator. Post-transplant cyclophosphamide will serve as the backbone of the immunosuppression treatment to prevent GVHD. All patients will receive a Haplo-identical stem cell transplantation. GVHD Prevention Treatment: Cyclophosphamide 50mg/kg will be administered IV on Day 3 and Day 5 post transplant. Tacrolimus 0.03 mg/kg daily will be administered IV until patient can take it by mouth starting on day of transplant and continue approximately 100 days post-transplant. Mycophenolate mofetil 15mg/kg will be administered twice a day IV until patient can take it by mouth starting on Day 1 post transplant until 28 days.