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Hematopoietic Stem Cell Support in Patients With Refractory Sarcoidosis

This study has been terminated.
(No plan to continue enrollment)
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier:
NCT00282438
First received: January 24, 2006
Last updated: January 3, 2017
Last verified: September 2016
Results First Received: September 12, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Sarcoidosis
Interventions: Biological: Autologous hematopoietic stem cell transplantation
Biological: Allogeneic stem cell transplantation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Autologous Hematopoietic Stem Cell Transplantation

Autologous stem cells will be injected after conditioning

Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning

Allogeneic Stem Cell Transplantation

Allogeneic stem cells will be injected after conditioning

Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning


Participant Flow:   Overall Study
    Autologous Hematopoietic Stem Cell Transplantation   Allogeneic Stem Cell Transplantation
STARTED   1   1 
COMPLETED   0   0 
NOT COMPLETED   1   1 
Lack of Efficacy                1                0 
Death                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Autologous Hematopoietic Stem Cell Transplantation

Autologous stem cells will be injected after conditioning

Autologous hematopoietic stem cell transplantation: Autologous hematopoietic stem cells will be injected after conditioning

Allogeneic Stem Cell Transplantation

Allogeneic stem cells will be injected after conditioning

Allogeneic stem cell transplantation: Allogeneic stem cells will be injected after conditioning

Total Total of all reporting groups

Baseline Measures
   Autologous Hematopoietic Stem Cell Transplantation   Allogeneic Stem Cell Transplantation   Total 
Overall Participants Analyzed 
[Units: Participants]
 1   1   2 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      1 100.0%      1 100.0%      2 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 54 [1]   49 [2]   51.5  (2.5) 
[1] Only one participant was analyzed and then the standard deviation could only be provided for the total column.
[2] Only one participant was analyzed and then the standard deviation could only be provided for the total column
Gender 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1 100.0%      1  50.0% 
Male      1 100.0%      0   0.0%      1  50.0% 
Region of Enrollment 
[Units: Participants]
     
United States   1   1   2 


  Outcome Measures

1.  Primary:   Toxicity   [ Time Frame: For length of hospital stay (until discharge). ]

2.  Primary:   Survival   [ Time Frame: Participants are to be followed at 6 months and then yearly until 5 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2020  

3.  Primary:   Time to Disease Progression   [ Time Frame: Participants are to be followed at 6 months and then yearly until 5 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2020  

4.  Primary:   Disease Improvement   [ Time Frame: Participants are to be followed at 6 months and then yearly until 5 years ]
Results not yet reported.   Anticipated Reporting Date:   04/2020  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Two patients had been enrolled on trial. One underwent autologous HSCT and relapsed early after the transplant. The second participant underwent allogeneic HSCT and died 70 days after the transplant and the study has been terminated.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr Richard Burt, Chief, Division of Immunotherapy, Department of Medicine
Organization: Northwestern University
phone: 312-695-4960
e-mail: rburt@northwestern.edu



Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00282438     History of Changes
Other Study ID Numbers: NU FDA SARC.2003
Study First Received: January 24, 2006
Results First Received: September 12, 2016
Last Updated: January 3, 2017