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Hematopoietic Stem Cell Support in Vasculitis

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ClinicalTrials.gov Identifier: NCT00278512
Recruitment Status : Terminated (No participant enrolled over five years. No plan to continue the study.)
First Posted : January 18, 2006
Results First Posted : August 2, 2018
Last Update Posted : August 2, 2018
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Vasculitis
Interventions Biological: Autologous Stem Cell Transplant
Biological: Allogeneic Stem Cell Transplant
Drug: Cyclophosphamide
Drug: ATG (rabbit)
Drug: G-CSF
Drug: Campath-1h
Drug: Fludarabine
Drug: Tacrolimus
Drug: Mesna
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Hide Arm/Group Description

Autologous Stem Cell Transplant will be performed on eligible patients

Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant will be performed on eligible patients

Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning

Period Title: Overall Study
Started 7 0
Completed 6 0
Not Completed 1 0
Reason Not Completed
Death             1             0
Arm/Group Title Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant Total
Hide Arm/Group Description

Autologous Stem Cell Transplant will be performed on eligible patients

Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant will be performed on eligible patients

Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning

Total of all reporting groups
Overall Number of Baseline Participants 7 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 7 participants
<=18 years
0
   0.0%
0
0
   0.0%
Between 18 and 65 years
7
 100.0%
0
7
 100.0%
>=65 years
0
   0.0%
0
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 7 participants 0 participants 7 participants
40.43  (12.03) 40.43  (12.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 7 participants 0 participants 7 participants
Female
6
  85.7%
0
6
  85.7%
Male
1
  14.3%
0
1
  14.3%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 7 participants 0 participants 7 participants
7
 100.0%
7
 100.0%
1.Primary Outcome
Title Survival
Hide Description Survival
Time Frame Up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Hide Arm/Group Description:

Autologous Stem Cell Transplant will be performed on eligible patients

Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant will be performed on eligible patients

Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning

Overall Number of Participants Analyzed 7 0
Measure Type: Count of Participants
Unit of Measure: Participants
6
  85.7%
0
Time Frame 6 months, 1 year, then yearly for at least 5 years post transplant
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Hide Arm/Group Description

Autologous Stem Cell Transplant will be performed on eligible patients

Autologous Stem Cell Transplant: Autologous Hematopoietic Stem Cell Transplant will be performed after conditioning

Allogeneic Stem Cell Transplant will be performed on eligible patients

Allogeneic Stem Cell Transplant: Allogeneic Stem Cell Transplant will be performed after conditioning

All-Cause Mortality
Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Affected / at Risk (%) Affected / at Risk (%)
Total   1/7 (14.29%)      0/0    
Show Serious Adverse Events Hide Serious Adverse Events
Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/7 (14.29%)      0/0    
Infections and infestations     
CMV Hepatitis  [1]  1/7 (14.29%)  1 0/0  0
Indicates events were collected by systematic assessment
[1]
One participant died of CMV hepatitis.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Autologous Stem Cell Transplant Allogeneic Stem Cell Transplant
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/7 (28.57%)      0/0    
Cardiac disorders     
Pulmonary Embolus   1/7 (14.29%)  1 0/0  0
Gastrointestinal disorders     
bowel obstruction  [1]  1/7 (14.29%)  1 0/0  0
Infections and infestations     
Swine flu  [2]  1/7 (14.29%)  1 0/0  0
Aspergillus  [3]  1/7 (14.29%)  1 0/0  0
Pseudomonas pneumonia  [4]  1/7 (14.29%)  1 0/0  0
Vascular disorders     
Deep Vein Thrombosis   1/7 (14.29%)  1 0/0  0
Indicates events were collected by systematic assessment
[1]
Two years after transplant had bowel obstruction due to pre transplant surgical scars-
[2]
One patient diagnosed with swine flu, requiring transient face mask oxygen and recovered.
[3]
One patient 4 years after transplant relapsed and was started on actemra. After 2 years of actemra ( a TNF inhibitor) patient developed aspergillus
[4]
One patient 4 years after transplant relapsed and was started on actemra. After 2 years of actemra ( a TNF inhibitor) patient developed pseudomonas pneumonia.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Richard Burt
Organization: Northwestern University
Phone: 312-695-4960
EMail: rburt@northwestern.edu
Layout table for additonal information
Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00278512     History of Changes
Other Study ID Numbers: DIAD Vasculitis.Auto2002
First Submitted: January 15, 2006
First Posted: January 18, 2006
Results First Submitted: June 20, 2017
Results First Posted: August 2, 2018
Last Update Posted: August 2, 2018