Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor

Brief Title

Study of Parathyroid Hormone Following Sequential Cord Blood Transplantation From an Unrelated Donor

Official Title

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

Brief 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.

Detailed Description

      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.

Study Phase

Phase 2

Study Type


Primary Outcome

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

Secondary Outcome

 Cumulative Incidence of Acute GVHD Grades II-IV at Day 100


Leukemia, Myeloid, Chronic


Parathyroid Hormone (teriparatide)

Study Arms / Comparison Groups

 Parathyroid Hormone (teriparatide)
Description:  Parathyroid hormone after double umbilical cord blood transplant.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

September 2006

Completion Date

March 2012

Primary Completion Date

November 2009

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

               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




18 Years - 45 Years

Accepts Healthy Volunteers



Karen K. Ballen, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Secondary IDs


Responsible Party


Study Sponsor

The Emmes Company, LLC


 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Karen K. Ballen, MD, Principal Investigator, Massachusetts General Hospital

Verification Date

April 2013