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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00393380
Recruitment Status : Terminated (Study stopped because of toxicity concerns.)
First Posted : October 27, 2006
Results First Posted : December 7, 2012
Last Update Posted : April 29, 2013
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The Emmes Company, LLC

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.

Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Chronic Anemia, Aplastic Myelofibrosis Lymphoma Hodgkin Disease Leukemia, Lymphocytic, Chronic Leukemia, Myelocytic, Acute Leukemia, Lymphocytic, Acute Drug: Parathyroid Hormone (teriparatide) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation
Study Start Date : September 2006
Actual Primary Completion Date : November 2009
Actual Study Completion Date : March 2012

Arm Intervention/treatment
Experimental: Parathyroid Hormone (teriparatide)
Parathyroid hormone after double umbilical cord blood transplant.
Drug: Parathyroid Hormone (teriparatide)
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
Other Names:
  • Parathyroid hormone
  • PTH
  • teriparatide

Primary Outcome Measures :
  1. Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500) [ Time Frame: Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge. ]
    Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)

Secondary Outcome Measures :
  1. Cumulative Incidence of Acute GVHD Grades II-IV at Day 100 [ Time Frame: Measured at Day 100 ]
    Cumulative Incidence of Acute GVHD Grades II-IV at day 100

  2. Cumulative Incidence of Chronic GVHD [ Time Frame: Measured at 2 years ]
    Cumulative Incidence of Chronic GVHD

  3. Platelet Engraftment (Greater Than 20,000) [ Time Frame: Measured at Day 180 ]
    Platelet engraftment (greater than 20,000)

  4. 100-day Transplant-related Mortality [ Time Frame: Measured at Day 100 ]
    100-day transplant-related mortality

  5. Cumulative Incidence of Relapse [ Time Frame: Measured at 2 years ]
    Cumulative Incidence of Relapse

  6. Overall Survival [ Time Frame: Measured at 2 years ]
    Overall Survival

  7. Disease-free Survival [ Time Frame: Measured at 1 year ]
    Disease-free survival

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00393380

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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The Emmes Company, LLC
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Karen K. Ballen, MD Massachusetts General Hospital
Principal Investigator: Joseph Antin, MD Dana-Farber Cancer Institute
Principal Investigator: David Avigan, MD Beth Israel Deaconess Medical Center
Principal Investigator: Elizabeth J Shpall, MD MD Anderson Cancer Research Center
Principal Investigator: Colleen Delaney, MD Fred Hutchinson Cancer Center
Principal Investigator: Ram Kamble, MD Baylor College of Medicine
Principal Investigator: Katarzyna Jamieson, M.D. University of Florida
Principal Investigator: Philip McCarthy, M.D. Roswell Park Cancer Institute
Principal Investigator: Edward Ball, M.D. University of California, San Diego
Principal Investigator: Richard Maziarz, M.D. Oregon Health and Science University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: The Emmes Company, LLC Identifier: NCT00393380    
Obsolete Identifiers: NCT00579722
Other Study ID Numbers: 435
U54HL081030-02 ( U.S. NIH Grant/Contract )
First Posted: October 27, 2006    Key Record Dates
Results First Posted: December 7, 2012
Last Update Posted: April 29, 2013
Last Verified: April 2013
Keywords provided by The Emmes Company, LLC:
Myelogenous Leukemia, Chronic
Parathyroid Hormone
Umbilical Cord Blood Stem Cell Transplantation
Additional relevant MeSH terms:
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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
Neoplasms by Histologic Type
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Bone Marrow Failure Disorders
Parathyroid Hormone
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Calcium-Regulating Hormones and Agents
Bone Density Conservation Agents