Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus

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: NCT00278538
Recruitment Status : Completed
First Posted : January 18, 2006
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
Sponsor:
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Systemic Lupus Erythematosus
Intervention Biological: Hematopoietic stem cell transplantation
Enrollment 32
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Autologous hematopoietic stem cell transplantation will be performed

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Period Title: Overall Study
Started 32
Completed 30
Not Completed 2
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Autologous hematopoietic stem cell transplantation will be performed

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
<=18 years
0
   0.0%
Between 18 and 65 years
32
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 32 participants
32
(16 to 60)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
30
  93.8%
Male
2
   6.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Hispanic or Latino
6
  18.8%
Not Hispanic or Latino
26
  81.3%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants
32
1.Primary Outcome
Title Survival
Hide Description The primary efficacy outcome is overall survival.
Time Frame 6 months, then yearly x 5 years after transplant
Hide Outcome Measure Data
Hide Analysis Population Description

The # analyzed at 6 mos.- 4 years differs from the overall participant # analyzed because 2 participants were declined HSCT due to comorbidities and 2 died within 6 mos. after HSCT unrelated to the treatment. The # analyzed at 5 years differs from the overall participants analyzed due to an unrelated treatment death at 4 years after HSCT.

.

Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description:

Autologous hematopoietic stem cell transplantation will be performed

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

Overall Number of Participants Analyzed 30
Measure Type: Count of Participants
Unit of Measure: Participants
6 Month Post Transplant Survival Number Analyzed 30 participants
Total Participant Survival
28
  93.3%
Non Treatment Related Death
2
   6.7%
1 Year Post Transplant Survival Number Analyzed 28 participants
Total Participant Survival
28
 100.0%
Non Treatment Related Death
0
   0.0%
2 Year Post Transplant Survival Number Analyzed 28 participants
Total Participant Survival
28
 100.0%
Non Treatment Related Death
0
   0.0%
3 Year Post Transplant Survival Number Analyzed 28 participants
Total Participant Survival
28
 100.0%
Non Treatment Related Death
0
   0.0%
4 Year Post Transplant Survival Number Analyzed 28 participants
Total Participant Survival
27
  96.4%
Non Treatment Related Death
1
   3.6%
5 Year Post Transplant Survival Number Analyzed 27 participants
Total Participant Survival
27
 100.0%
Non Treatment Related Death
0
   0.0%
Time Frame 5 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Hematopoietic Stem Cell Transplantation
Hide Arm/Group Description

Autologous hematopoietic stem cell transplantation will be performed

Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation

All-Cause Mortality
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%)
Total   3/30 (10.00%)    
Hide Serious Adverse Events
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   5/30 (16.67%)    
Cardiac disorders   
Elevated Troponin  [1]  1/30 (3.33%)  1
General disorders   
Intracranial Hemorrhage  [1]  1/30 (3.33%)  1
Metabolism and nutrition disorders   
Hypokalemia  [1]  3/30 (10.00%)  3
Indicates events were collected by systematic assessment
[1]
Grade 4 Toxicity During HSCT Hospitalization
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Hematopoietic Stem Cell Transplantation
Affected / at Risk (%) # Events
Total   10/30 (33.33%)    
Cardiac disorders   
Hypertension  [1]  7/30 (23.33%)  7
Chest Pain  [1]  2/30 (6.67%)  2
General disorders   
Dyspnea  [1]  5/30 (16.67%)  5
Elevated Transaminase  [1]  2/30 (6.67%)  2
Infections and infestations   
Neutropenic Fevers  [1]  10/30 (33.33%)  10
Metabolism and nutrition disorders   
Hypokalemia  [1]  8/30 (26.67%)  8
Hyperglycemia  [1]  6/30 (20.00%)  6
Hypophosphatemia  [1]  5/30 (16.67%)  5
Hypomagnesemia  [1]  3/30 (10.00%)  3
Hypocalcemia  [1]  3/30 (10.00%)  3
Indicates events were collected by systematic assessment
[1]
Grade 3 Toxicity During HSCT Hospitalization
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: Kathleen Quigley
Organization: Northwestern University
Phone: 312-695-8192
EMail: k-quigley@northwestern.edu
Layout table for additonal information
Responsible Party: Richard Burt, MD, Northwestern University
ClinicalTrials.gov Identifier: NCT00278538    
Other Study ID Numbers: DI SLE.Auto2003
First Submitted: January 15, 2006
First Posted: January 18, 2006
Results First Submitted: November 18, 2019
Results First Posted: February 28, 2020
Last Update Posted: February 28, 2020