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

This study has been terminated.
(Study stopped because of toxicity concerns.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
The EMMES Corporation
ClinicalTrials.gov Identifier:
NCT00393380
First received: October 25, 2006
Last updated: April 22, 2013
Last verified: April 2013
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase II Study of Parathyroid Hormone Following Myeloablative Sequential Unrelated Cord Blood Transplantation

Resource links provided by NLM:


Further study details as provided by The EMMES Corporation:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Median time to neutrophil engraftment (defined as an absolute neutrophil count [ANC] greater than 500)


Secondary Outcome Measures:
  • Cumulative Incidence of Acute GVHD Grades II-IV at Day 100 [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]
    Cumulative Incidence of Acute GVHD Grades II-IV at day 100

  • Cumulative Incidence of Chronic GVHD [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]
    Cumulative Incidence of Chronic GVHD

  • Platelet Engraftment (Greater Than 20,000) [ Time Frame: Measured at Day 180 ] [ Designated as safety issue: No ]
    Platelet engraftment (greater than 20,000)

  • 100-day Transplant-related Mortality [ Time Frame: Measured at Day 100 ] [ Designated as safety issue: No ]
    100-day transplant-related mortality

  • Cumulative Incidence of Relapse [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]
    Cumulative Incidence of Relapse

  • Overall Survival [ Time Frame: Measured at 2 years ] [ Designated as safety issue: No ]
    Overall Survival

  • Disease-free Survival [ Time Frame: Measured at 1 year ] [ Designated as safety issue: No ]
    Disease-free survival


Enrollment: 13
Study Start Date: September 2006
Study Completion Date: March 2012
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393380

Locations
United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The EMMES Corporation
Investigators
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 Research 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
  More Information

No publications provided by The EMMES Corporation

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: The EMMES Corporation
ClinicalTrials.gov Identifier: NCT00393380     History of Changes
Obsolete Identifiers: NCT00579722
Other Study ID Numbers: 435, U54HL081030-02
Study First Received: October 25, 2006
Results First Received: November 6, 2012
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by The EMMES Corporation:
Myelogenous Leukemia, Chronic
Myelodysplasia
Parathyroid Hormone
Umbilical Cord Blood Stem Cell Transplantation

Additional relevant MeSH terms:
Leukemia
Primary Myelofibrosis
Hodgkin Disease
Leukemia, Myeloid
Leukemia, Lymphoid
Leukemia, Myelogenous, Chronic, BCR-ABL Positive
Leukemia, Lymphocytic, Chronic, B-Cell
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Anemia, Aplastic
Neoplasms by Histologic Type
Neoplasms
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases
Lymphoma
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Leukemia, B-Cell
Anemia
Hormones
Teriparatide
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on October 01, 2014