Cyclophosphamide and Rabbit Antithymocyte Globulin (rATG)/Rituximab in Patients With Systemic Lupus Erythematosus
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ClinicalTrials.gov Identifier: NCT00278538 |
Recruitment Status :
Completed
First Posted : January 18, 2006
Results First Posted : February 28, 2020
Last Update Posted : February 28, 2020
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Sponsor:
Northwestern University
Information provided by (Responsible Party):
Richard Burt, MD, Northwestern University
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Study Type | Interventional |
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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 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Hematopoietic Stem Cell Transplantation |
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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 |
Baseline Characteristics
Arm/Group Title | Hematopoietic Stem Cell Transplantation | |
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Autologous hematopoietic stem cell transplantation will be performed Hematopoietic stem cell transplantation: Autologous hematopoietic stem cell transplantation |
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Overall Number of Baseline Participants | 32 | |
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[Not Specified]
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Age, Categorical
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 32 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
32 100.0%
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>=65 years |
0 0.0%
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 32 participants | |
32
(16 to 60)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 32 participants | |
Female |
30 93.8%
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Male |
2 6.3%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 32 participants | |
Hispanic or Latino |
6 18.8%
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Not Hispanic or Latino |
26 81.3%
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Unknown or Not Reported |
0 0.0%
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Region of Enrollment
Measure Type: Number Unit of measure: Participants |
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United States | Number Analyzed | 32 participants |
32 |
Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Kathleen Quigley |
Organization: | Northwestern University |
Phone: | 312-695-8192 |
EMail: | k-quigley@northwestern.edu |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 |