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

April 22, 2013 updated by: The Emmes Company, LLC

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
      • Boston, Massachusetts, United States, 02115
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / 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:
  • PTH
  • teriparatide
  • Parathyroid hormone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Statistic is calculated at Day 42 but ANC counts are measured daily up through discharge.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured at Day 100
Cumulative Incidence of Chronic GVHD
Time Frame: Measured at 2 years
Cumulative Incidence of Chronic GVHD
Measured at 2 years
Platelet Engraftment (Greater Than 20,000)
Time Frame: Measured at Day 180
Platelet engraftment (greater than 20,000)
Measured at Day 180
100-day Transplant-related Mortality
Time Frame: Measured at Day 100
100-day transplant-related mortality
Measured at Day 100
Cumulative Incidence of Relapse
Time Frame: Measured at 2 years
Cumulative Incidence of Relapse
Measured at 2 years
Overall Survival
Time Frame: Measured at 2 years
Overall Survival
Measured at 2 years
Disease-free Survival
Time Frame: Measured at 1 year
Disease-free survival
Measured at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Emmes Company, LLC

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Karen K. Ballen, MD, Massachusetts General Hospital
  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (ACTUAL)

November 1, 2009

Study Completion (ACTUAL)

March 1, 2012

Study Registration Dates

First Submitted

October 25, 2006

First Submitted That Met QC Criteria

October 25, 2006

First Posted (ESTIMATE)

October 27, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

April 29, 2013

Last Update Submitted That Met QC Criteria

April 22, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 435
  • U54HL081030-02 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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