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A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

Phase 2
18 Years
45 Years
Not Enrolling
Leukemia, Myeloid, Chronic, Anemia, Aplastic, Myelofibrosis, Lymphoma, Hodgkin Disease, Leukemia, Lymphocytic, Chronic, Leukemia, Myelocytic, Acute, Leukemia, Lymphocytic, Acute

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Trial Information

A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

In this phase II, single stage study, participants will include 40 adults who are candidates
for a hematopoietic stem cell transplant. All participants will undergo a sequential cord
blood transplant using a well-known myeloablative regimen of fludarabine, cyclophosphamide,
and total body irradiation, which is appropriate for those individuals who are likely to
benefit from an ablative regimen. Tacrolimus will be combined with mycophenolate mofetil
(MMF) for the graft-versus-host disease (GVHD) prophylaxis regimen. Parathyroid hormone
(PTH) will be added to this regimen in an attempt to improve engraftment. PTH is an
approved drug with minimal side effects in individuals with osteoporosis; the dose of PTH
has been determined from a phase I study in individuals with hematologic cancer.

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

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

- 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

- 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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)

Outcome Description:

Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)

Outcome Time Frame:

Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.

Safety Issue:


Principal Investigator

Karen K. Ballen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

September 2006

Completion Date:

March 2012

Related Keywords:

  • Leukemia, Myeloid, Chronic
  • Anemia, Aplastic
  • Myelofibrosis
  • Lymphoma
  • Hodgkin Disease
  • Leukemia, Lymphocytic, Chronic
  • Leukemia, Myelocytic, Acute
  • Leukemia, Lymphocytic, Acute
  • Myelogenous Leukemia, Chronic
  • Myelodysplasia
  • Parathyroid Hormone
  • Umbilical Cord Blood Stem Cell Transplantation
  • Primary Myelofibrosis
  • Anemia
  • Anemia, Aplastic
  • Hodgkin Disease
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Leukemia, Myelogenous, Chronic, BCR-ABL Positive
  • Lymphoma



Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Massachusetts General HospitalBoston, Massachusetts  02114-2617
University of FloridaGainesville, Florida  32610-0277
Dana Farber Cancer InstituteBoston, Massachusetts  02115