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Hematopoietic Stem Cell Support in Vasculitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Name/Title: Dr Richard Burt
Organization: Northwestern University
Phone: 312-695-4960
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