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

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ClinicalTrials.gov Identifier: NCT00393380
Recruitment Status : Terminated (Study stopped because of toxicity concerns.)
First Posted : October 27, 2006
Results First Posted : December 7, 2012
Last Update Posted : April 29, 2013
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
The Emmes Company, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Leukemia, Myeloid, Chronic
Anemia, Aplastic
Myelofibrosis
Lymphoma
Hodgkin Disease
Leukemia, Lymphocytic, Chronic
Leukemia, Myelocytic, Acute
Leukemia, Lymphocytic, Acute
Intervention Drug: Parathyroid Hormone (teriparatide)
Enrollment 13
Recruitment Details 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.
Pre-assignment Details Thirteen patients who were enrolled proceeded to the cord blood transplant.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description Parathyroid hormone after double umbilical cord blood transplant.
Period Title: Overall Study
Started 13
Completed 13
Not Completed 0
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Baseline Participants 13
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
<=18 years
0
   0.0%
Between 18 and 65 years
11
  84.6%
>=65 years
2
  15.4%
Age Continuous   [1] 
Median (Full Range)
Unit of measure:  Years
Number Analyzed 13 participants
39
(25 to 67)
[1]
Measure Description: Median Age at Transplant
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
Female
6
  46.2%
Male
7
  53.8%
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   7.7%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
10
  76.9%
More than one race
2
  15.4%
Unknown or Not Reported
0
   0.0%
[1]
Measure Description: Race among patients transplanted.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 13 participants
13
1.Primary Outcome
Title Median Time to Neutrophil Engraftment (Defined as an Absolute Neutrophil Count [ANC] Greater Than 500)
Hide Description 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.
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients received the transplant.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Median (Full Range)
Unit of Measure: days
30
(19 to 37)
2.Secondary Outcome
Title Cumulative Incidence of Acute GVHD Grades II-IV at Day 100
Hide Description Cumulative Incidence of Acute GVHD Grades II-IV at day 100
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(10.3 to 66.7)
3.Secondary Outcome
Title Cumulative Incidence of Chronic GVHD
Hide Description Cumulative Incidence of Chronic GVHD
Time Frame Measured at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(8.1 to 68.9)
4.Secondary Outcome
Title Platelet Engraftment (Greater Than 20,000)
Hide Description Platelet engraftment (greater than 20,000)
Time Frame Measured at Day 180
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
46.2
(17.0 to 76.0)
5.Secondary Outcome
Title 100-day Transplant-related Mortality
Hide Description 100-day transplant-related mortality
Time Frame Measured at Day 100
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Unit of Measure: participants
4
6.Secondary Outcome
Title Cumulative Incidence of Relapse
Hide Description Cumulative Incidence of Relapse
Time Frame Measured at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
15.4
(0.0 to 36.2)
7.Secondary Outcome
Title Overall Survival
Hide Description Overall Survival
Time Frame Measured at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(14.1 to 62.8)
8.Secondary Outcome
Title Disease-free Survival
Hide Description Disease-free survival
Time Frame Measured at 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
13 patients were transplanted.
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description:
Parathyroid hormone after double umbilical cord blood transplant.
Overall Number of Participants Analyzed 13
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
38.5
(14.1 to 62.8)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Parathyroid Hormone (Teriparatide)
Hide Arm/Group Description Parathyroid hormone after double umbilical cord blood transplant.
All-Cause Mortality
Parathyroid Hormone (Teriparatide)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Parathyroid Hormone (Teriparatide)
Affected / at Risk (%) # Events
Total   8/13 (61.54%)    
General disorders   
Death  [1]  8/13 (61.54%)  8
Indicates events were collected by systematic assessment
[1]
Death
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Parathyroid Hormone (Teriparatide)
Affected / at Risk (%) # Events
Total   8/13 (61.54%)    
General disorders   
Death  8/13 (61.54%)  8
The study was closed prematurely due to early mortality and lack of efficacy.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Adam Mendizabal, Statistician
Organization: The EMMES Corporation
Phone: 301-251-1161 ext 221
Responsible Party: The Emmes Company, LLC
ClinicalTrials.gov Identifier: NCT00393380     History of Changes
Obsolete Identifiers: NCT00579722
Other Study ID Numbers: 435
U54HL081030-02 ( U.S. NIH Grant/Contract )
First Submitted: October 25, 2006
First Posted: October 27, 2006
Results First Submitted: November 6, 2012
Results First Posted: December 7, 2012
Last Update Posted: April 29, 2013