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Trial record 34 of 215 for:    Inflammatory Myopathies

Stem Cell Transplantation in Idiopathic Inflammatory Myopathy Diseases

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ClinicalTrials.gov Identifier: NCT00278564
Recruitment Status : Terminated (high relapse rate)
First Posted : January 18, 2006
Results First Posted : August 6, 2018
Last Update Posted : August 6, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition MYOPATHY
Interventions Biological: Hematopoietic stem cell transplantation
Drug: Cyclophosphamide
Drug: Mesna
Drug: ATG(rabbit)
Drug: Methylprednisolone
Drug: G-CSF
Drug: Rituxan
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hematopoietic Stem Cell Transplantation
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Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Period Title: Overall Study
Started 7
Completed 3
Not Completed 4
Reason Not Completed
Lack of Efficacy             4
Arm/Group Title Hematopoietic Stem Cell Transplantation
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Intervention as hematopoietic stem cells transplantation after conditioning regimen: Autologous hematopoietic stem cells will be injected after conditioning regimen

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Overall Number of Baseline Participants 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants
37  (8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants
Female
7
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants
7
 100.0%
1.Primary Outcome
Title Survival
Hide Description Survival
Time Frame up to 5 years
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Hide Analysis Population Description
All participants who underwent stem cell transplantation
Arm/Group Title Hematopoietic Stem Cell Transplantation
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Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 7
Measure Type: Count of Participants
Unit of Measure: Participants
7
 100.0%
Time Frame 6 months, 1 year, then yearly up to 5 years post transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Intervention as autologous hematopoietic stem cell transplantation after conditioning regimen

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

All-Cause Mortality
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%)
Total   0/7 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   0/7 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   4/7 (57.14%)    
General disorders   
Viral infection  [1]  1/7 (14.29%)  2
hypokalemia * [2]  1/7 (14.29%)  1
Infections and infestations   
Sinusitis  [3]  2/7 (28.57%)  2
Indicates events were collected by systematic assessment
[1]
one hospitalization for transient nausea, vomiting and diarrhea-- no documented etiology.
*
Indicates events were collected by non-systematic assessment
[2]
One patient had transient asymptomatic grade 4 hypokalemia during transplant.
[3]
Two patients had sinusitis treated with oral antibiotics and IVIG and resolved with treatment.
Early termination leading to small numbers of subjects analyzed
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Richard Burt
Organization: Northwestern University
Phone: 312-695-4960
Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00278564     History of Changes
Other Study ID Numbers: NU FDA IIM.Auto2003
First Submitted: January 15, 2006
First Posted: January 18, 2006
Results First Submitted: June 20, 2017
Results First Posted: August 6, 2018
Last Update Posted: August 6, 2018