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Trial · Interventional

TerminatedPhase 2Results postedRegistry data

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

NCTNCT00393380 (opens ClinicalTrials.gov in a new tab)Other id435Other idU54HL081030-02
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Terminated
Phase
Phase 2
Enrollment
13 participants (actual)
Sponsor
The Emmes Company, LLC · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United States

Start
Sept 2006
Primary completion
Nov 2009
Completion
Mar 2012
First posted
27 Oct 2006 (estimated)
Last update posted
29 Apr 2013 (estimated)
Conditions
Leukemia, Myeloid, Chronic · Anemia, Aplastic · Myelofibrosis · Lymphoma · Hodgkin Disease · Leukemia, Lymphocytic, Chronic · Leukemia, Myelocytic, Acute · Leukemia, Lymphocytic, Acute

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2006200820102012
  1. Ph 2

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

    NCT00393380

    Sept 2006 to Mar 2012

    Terminated

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Parathyroid Hormone (teriparatide)Drug

Arms1

  • Experimental

    Parathyroid Hormone (teriparatide)

    Parathyroid hormone after double umbilical cord blood transplant.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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.

    Registry description

    Median time to neutrophil engraftment (defined as an absolute neutrophil count \[ANC\] greater than 500)

Secondary outcomes(7)

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

    Time frame · Measured at Day 100

    Registry description

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

  2. Cumulative Incidence of Chronic GVHD

    Time frame · Measured at 2 years

    Registry description

    Cumulative Incidence of Chronic GVHD

  3. Platelet Engraftment (Greater Than 20,000)

    Time frame · Measured at Day 180

    Registry description

    Platelet engraftment (greater than 20,000)

  4. 100-day Transplant-related Mortality

    Time frame · Measured at Day 100

    Registry description

    100-day transplant-related mortality

  5. Cumulative Incidence of Relapse

    Time frame · Measured at 2 years

    Registry description

    Cumulative Incidence of Relapse

  6. Overall Survival

    Time frame · Measured at 2 years

    Registry description

    Overall Survival

  7. Disease-free Survival

    Time frame · Measured at 1 year

    Registry description

    Disease-free survival

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 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)

GroupValue (days)
Parathyroid Hormone (Teriparatide)30
Secondary and other outcome results(7)
Secondary outcomeNumber· Measured at Day 100

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

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)38.5
Secondary outcomeNumber· Measured at 2 years

Cumulative Incidence of Chronic GVHD

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)38.5
Secondary outcomeNumber· Measured at Day 180

Platelet Engraftment (Greater Than 20,000)

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)46.2
Secondary outcomeNumber· Measured at Day 100

100-day Transplant-related Mortality

GroupValue (participants)
Parathyroid Hormone (Teriparatide)4
Secondary outcomeNumber· Measured at 2 years

Cumulative Incidence of Relapse

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)15.4
Secondary outcomeNumber· Measured at 2 years

Overall Survival

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)38.5
Secondary outcomeNumber· Measured at 1 year

Disease-free Survival

GroupValue (percentage of participants)
Parathyroid Hormone (Teriparatide)38.5

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Parathyroid Hormone (Teriparatide)Parathyroid hormone after double umbilical cord blood transplant.–8 / 138 / 13

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedBallen 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

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 45 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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