CClinicalTrials.gg
Sign In
TerminatedNCT00393380Updated Apr 29, 2013Results posted

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

A Phase 2 interventional study of Parathyroid Hormone (teriparatide) in Leukemia, Myeloid, Chronic, Anemia, Aplastic and Myelofibrosis, sponsored by The Emmes Company, LLC. Terminated at 4 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2013-04-29.

Sponsored by The Emmes Company, LLC · Phase 2, Interventional, and Prevention

Why this study was terminated
Study stopped because of toxicity concerns.
Phase
Phase 2
Study type
Interventional
Enrollment
13
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Leukemia, Myeloid, Chronic
  • Anemia, Aplastic
  • Myelofibrosis
  • Lymphoma
  • Hodgkin Disease
  • Leukemia, Lymphocytic, Chronic
  • Leukemia, Myelocytic, Acute
  • Leukemia, Lymphocytic, Acute

Keywords

  • Myelogenous Leukemia, Chronic
  • Myelodysplasia
  • Parathyroid Hormone
  • Umbilical Cord Blood Stem Cell Transplantation
03

In context

Leukemia

5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.

This study's enrollment of 13 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.

Browse Leukemia studies →

Lead sponsor

The Emmes Company, LLC is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
13 participants (actual)

Study arms

  • Experimental
    Parathyroid Hormone (teriparatide)

    Parathyroid hormone after double umbilical cord blood transplant.

    Drug: Parathyroid Hormone (teriparatide)

Interventions

  • DrugParathyroid 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

    Also known as: Parathyroid hormone, PTH, teriparatide

06

What researchers measure

Primary outcomes

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

    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.

Secondary outcomes

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

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

    Time frame: Measured at Day 100

  2. Cumulative Incidence of Chronic GVHD

    Cumulative Incidence of Chronic GVHD

    Time frame: Measured at 2 years

  3. Platelet Engraftment (Greater Than 20,000)

    Platelet engraftment (greater than 20,000)

    Time frame: Measured at Day 180

  4. 100-day Transplant-related Mortality

    100-day transplant-related mortality

    Time frame: Measured at Day 100

  5. Cumulative Incidence of Relapse

    Cumulative Incidence of Relapse

    Time frame: Measured at 2 years

  6. Overall Survival

    Overall Survival

    Time frame: Measured at 2 years

  7. Disease-free Survival

    Disease-free survival

    Time frame: Measured at 1 year

07

Results

Posted Dec 7, 2012
Limitations and caveats
The study was closed prematurely due to early mortality and lack of efficacy.

Participant flow

Thirteen patients were enrolled on the study between October 25, 2006 and March 27, 2008 from three centers. Dana Farber Cancer Institute enrolled 10 patients, University of Florida enrolled 2 patients and Massachusetts General Hospital enrolled 1 patient.

Participant flow — Overall Study
MilestoneParathyroid Hormone (Teriparatide)
Started13
Completed13
Not completed0

Outcome measures

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

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.
Reported as:
Median · days
Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)
daysParathyroid Hormone (Teriparatide)
Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)30 (19 to 37)
SecondaryCumulative Incidence of Acute GVHD Grades II-IV at Day 100

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

Time frame:
Measured at Day 100
Reported as:
Number · percentage of participants
Cumulative Incidence of Acute GVHD Grades II-IV at Day 100
percentage of participantsParathyroid Hormone (Teriparatide)
Cumulative Incidence of Acute GVHD Grades II-IV at Day 10038.5 (10.3 to 66.7)
SecondaryCumulative Incidence of Chronic GVHD

Cumulative Incidence of Chronic GVHD

Time frame:
Measured at 2 years
Reported as:
Number · percentage of participants
Cumulative Incidence of Chronic GVHD
percentage of participantsParathyroid Hormone (Teriparatide)
Cumulative Incidence of Chronic GVHD38.5 (8.1 to 68.9)
SecondaryPlatelet Engraftment (Greater Than 20,000)

Platelet engraftment (greater than 20,000)

Time frame:
Measured at Day 180
Reported as:
Number · percentage of participants
Platelet Engraftment (Greater Than 20,000)
percentage of participantsParathyroid Hormone (Teriparatide)
Platelet Engraftment (Greater Than 20,000)46.2 (17.0 to 76.0)
Secondary100-day Transplant-related Mortality

100-day transplant-related mortality

Time frame:
Measured at Day 100
Reported as:
Number · participants
100-day Transplant-related Mortality
participantsParathyroid Hormone (Teriparatide)
100-day Transplant-related Mortality4
SecondaryCumulative Incidence of Relapse

Cumulative Incidence of Relapse

Time frame:
Measured at 2 years
Reported as:
Number · percentage of participants
Cumulative Incidence of Relapse
percentage of participantsParathyroid Hormone (Teriparatide)
Cumulative Incidence of Relapse15.4 (0.0 to 36.2)
SecondaryOverall Survival

Overall Survival

Time frame:
Measured at 2 years
Reported as:
Number · percentage of participants
Overall Survival
percentage of participantsParathyroid Hormone (Teriparatide)
Overall Survival38.5 (14.1 to 62.8)
SecondaryDisease-free Survival

Disease-free survival

Time frame:
Measured at 1 year
Reported as:
Number · percentage of participants
Disease-free Survival
percentage of participantsParathyroid Hormone (Teriparatide)
Disease-free Survival38.5 (14.1 to 62.8)

Adverse events

Collected over 2 years. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Parathyroid Hormone (Teriparatide)—8/13 (61.5%)8/13 (61.5%)
Most frequent serious events
Most frequent serious events
EventParathyroid Hormone (Teriparatide)
DeathGeneral disorders8/13
Most frequent other events
Most frequent other events
EventParathyroid Hormone (Teriparatide)
DeathGeneral disorders8/13

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Parathyroid Hormone (Teriparatide)
<=18 years0
Between 18 and 65 years11
>=65 years2
Age Continuous
Age Continuous(years)Parathyroid Hormone (Teriparatide)
Median39 (25 to 67)
Sex: Female, Male
Sex: Female, Male(Participants)Parathyroid Hormone (Teriparatide)
Female6
Male7
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Parathyroid Hormone (Teriparatide)
American Indian or Alaska Native0
Asian1
Native Hawaiian or Other Pacific Islander0
Black or African American0
White10
More than one race2
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Parathyroid Hormone (Teriparatide)
United States13
08

Study locations

4 sites
  • University of Florida
    Gainesville, Florida 32610, United States
  • Massachusetts General Hospital
    Boston, Massachusetts 02114, United States
  • Beth Israel Deaconess Medical Center
    Boston, Massachusetts 02115, United States
  • Dana Farber Cancer Institute
    Boston, Massachusetts 02115, United States
09

References and documents

Publications

  • Ballen K, Mendizabal AM, Cutler C, Politikos I, Jamieson K, Shpall EJ, Dey BR, Attar E, McAfee S, Delaney C, McCarthy P, Ball ED, Kamble R, Avigan D, Maziarz RT, Ho VT, Koreth J, Alyea E, Soiffer R, Wingard JR, Boussiotis V, Spitzer TR, Antin JH. Phase II trial of parathyroid hormone after double umbilical cord blood transplantation. Biol Blood Marrow Transplant. 2012 Dec;18(12):1851-8. doi: 10.1016/j.bbmt.2012.06.016. Epub 2012 Jul 2. PubMed 22766223 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00393380
Lead sponsor
The Emmes Company, LLC
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Responsible party
Sponsor
First posted
Oct 27, 2006
Start date
Sep 2006
Primary completion
Nov 2009
Completion
Mar 2012
Results posted
Dec 7, 2012
Last update
Apr 29, 2013

Study contacts

Karen K. Ballen, MD
principal investigator · Massachusetts General Hospital
Joseph Antin, MD
principal investigator · Dana-Farber Cancer Institute
David Avigan, MD
principal investigator · Beth Israel Deaconess Medical Center
Elizabeth J Shpall, MD
principal investigator · MD Anderson Cancer Research Center
Colleen Delaney, MD
principal investigator · Fred Hutchinson Cancer Center
Ram Kamble, MD
principal investigator · Baylor College of Medicine
Katarzyna Jamieson, M.D.
principal investigator · University of Florida
Philip McCarthy, M.D.
principal investigator · Roswell Park Cancer Institute
Edward Ball, M.D.
principal investigator · University of California, San Diego
Richard Maziarz, M.D.
principal investigator · Oregon Health and Science University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Leukemia→

Other studies from this sponsor

The Emmes Company, LLC

Start the discussion