Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor
Condition: Leukemia, Myeloid, Chronic; Anemia, Aplastic; Myelofibrosis; Lymphoma; Hodgkin Disease; Leukemia, Lymphocytic, Chronic; Leukemia, Myelocytic, Acute; Leukemia, Lymphocytic, Acute
MeSH terms: Leukemia; Hodgkin Disease; Leukemia, Myeloid; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Anemia, Aplastic
Intervention: Parathyroid Hormone (teriparatide)
Intervention description: Day +1: PTH 40 mcg, Day +2: PTH 60 mcg, Day +3: PTH 80 mcg, Day +4 to Day +29 or until ANC>2000/microL: PTH 100 mcg
Intervention MeSH terms: Teriparatide; Hormones; Parathyroid Hormone
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 13.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No
Keywords: Myelogenous Leukemia, Chronic; Myelodysplasia; Parathyroid Hormone; Umbilical Cord Blood Stem Cell Transplantation

Summary:

      The purpose of this study is to determine whether the addition of parathyroid hormone after a
      sequential cord blood transplant will improve engraftment, which is the ability of the
      transplanted stem cells to grow and to successfully begin producing new blood cells.
    

Eligibility criteria:

        Inclusion Criteria:

          -  One of the following diagnoses:

               1. Chronic myelogenous leukemia (CML) accelerated phase or second stable phase;
                  individuals in the first chronic phase are eligible if they have resistance to
                  imatinib

               2. Myelodysplasia

               3. Aplastic anemia that is not responding to immunosuppressive therapy

               4. Myelofibrosis, either primary or secondary to polycythemia vera

               5. Relapsed lymphoma or Hodgkin's disease

               6. Stage III/IV chronic lymphocytic leukemia (CLL), relapsed after or refractory to
                  at least one fludarabine containing regimen

               7. Acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) in
                  complete remission (CR) 2 or greater, or CR 1 with high risk features

          -  No prior autologous stem cell transplant

          -  Eastern Cooperative Oncology Group (ECOG) performance status of less than 2

          -  Lack of 6/6 or 5/6 matched related donor OR lack of 10/10 matched unrelated donor OR
             no available donor in the appropriate time frame to perform a potentially curative
             stem cell transplant

          -  Diffusing capacity of the lung for carbon monoxide (DLCO) greater than 50% of
             predicted value

          -  Left ventricular ejection fraction (LVEF) greater than 50% of predicted value

          -  Calcium levels less than 10.5 mg/dl

          -  Phosphate levels greater than 1.6 mg/dl

        Exclusion Criteria:

          -  Heart disease, as determined by symptomatic congestive heart failure, radionuclide
             ventriculogram (RVG), or echocardiogram-determined LVEF of less than 50%, active
             angina pectoris, or uncontrolled high blood pressure

          -  Pulmonary disease, as determined by severe chronic obstructive lung disease,
             symptomatic restrictive lung disease, or corrected DLCO of less than 50% of predicted
             value

          -  Kidney disease, as determined by serum creatinine levels greater than 2.0 mg/dl

          -  Liver disease, as determined by serum bilirubin levels greater than 2.0 mg/dl (except
             in the case of Gilbert's syndrome or hemolytic anemia in which the bilirubin can be
             elevated greater than 2.0mg/dl), SGOT or SGPT greater than 3 times the upper limit of
             normal

          -  Neurologic disease, as determined by symptomatic leukoencephalopathy, active central
             nervous system (CNS) cancer, or other neuropsychiatric abnormalities that may prevent
             transplantation (previous CNS cancer and presently in CR is acceptable)

          -  HIV antibodies

          -  Uncontrolled infection

          -  Pregnant or breastfeeding