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NCT00393380 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2013-04-29

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Cumulative Incidence of Chronic GVHD

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outcome · POSTED

Platelet Engraftment (Greater Than 20,000)

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outcome · POSTED

100-day Transplant-related Mortality

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outcome · POSTED

Cumulative Incidence of Relapse

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outcome · POSTED

Overall Survival

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outcome · POSTED

Disease-free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
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 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
healthy Volunteers
false
maximum Age
45 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Parathyroid hormone after double umbilical cord blood transplant.
    intervention Names
    1. Drug: Parathyroid Hormone (teriparatide)
    label
    Parathyroid Hormone (teriparatide)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Parathyroid Hormone (teriparatide)
    description
    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
    name
    Parathyroid Hormone (teriparatide)
    other Names
    1. Parathyroid hormone
    2. PTH
    3. teriparatide
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
PREVENTION
Enrollment
count
13
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)
    measure
    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. description
    Cumulative Incidence of Acute GVHD Grades II-IV at day 100
    measure
    Cumulative Incidence of Acute GVHD Grades II-IV at Day 100
    time Frame
    Measured at Day 100
  2. description
    Cumulative Incidence of Chronic GVHD
    measure
    Cumulative Incidence of Chronic GVHD
    time Frame
    Measured at 2 years
  3. description
    Platelet engraftment (greater than 20,000)
    measure
    Platelet Engraftment (Greater Than 20,000)
    time Frame
    Measured at Day 180
  4. description
    100-day transplant-related mortality
    measure
    100-day Transplant-related Mortality
    time Frame
    Measured at Day 100
  5. description
    Cumulative Incidence of Relapse
    measure
    Cumulative Incidence of Relapse
    time Frame
    Measured at 2 years
  6. description
    Overall Survival
    measure
    Overall Survival
    time Frame
    Measured at 2 years
  7. description
    Disease-free survival
    measure
    Disease-free Survival
    time Frame
    Measured at 1 year
Full study description
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.
Source references
references
  1. citation
    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.
    pmid
    22766223
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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      occurrences
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        exact text
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        start
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      offset unit
      unicode_code_points
      query cond
      Parathyroid Cancer
      query disease state id
      ds-parathyroid-cancer
      source file
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      source file sha256
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      source kind
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      source record id
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      source string sha256
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    Preserved source evidence · Not medical advice