Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
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ClinicalTrials.gov Identifier: NCT02080195 |
Recruitment Status :
Terminated
(Study was unable to accrue subjects)
First Posted : March 6, 2014
Results First Posted : October 2, 2018
Last Update Posted : October 2, 2019
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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 |
Conditions |
Lupus Erythematosus Graft-versus-host Disease |
Interventions |
Drug: Cyclophosphamide Drug: Fludarabine Drug: Tacrolimus Drug: Mycophenolate Mofetil Drug: Rabbit antithymocyte globulin Radiation: Total body irradiation Biological: Allogeneic bone marrow transplant |
Enrollment | 1 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Nonmyeloablative Conditioning and BMT |
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Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent Fludarabine monophosphate: Purine antimetabolite Tacrolimus: Calcineurin inhibitor Mofetil: Immunosuppressant Rabbit antithymocyte globulin: Selective immunosuppressant |
Period Title: Overall Study | |
Started | 1 |
Completed | 1 |
Not Completed | 0 |
Arm/Group Title | Nonmyeloablative Conditioning and BMT | |
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Nonmyeloablative Conditioning and Bone Marrow Transplant in Systemic Lupus Erythematosus patients Cyclophosphamide: Cyclophosphamide (alkylating agent) conditioning regimen and post transplantation cyclophosphamide with matched, partially matched, haplo-identical or unrelated donors Sodium-2-mercapto ethane sulphonate: Antineoplastic detoxifying agent Fludarabine monophosphate: Purine antimetabolite Tacrolimus: Calcineurin inhibitor Mofetil: Immunosuppressant Rabbit antithymocyte globulin: Selective immunosuppressant |
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Overall Number of Baseline Participants | 1 | |
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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 | 1 participants | |
<=18 years |
0 0.0%
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Between 18 and 65 years |
1 100.0%
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>=65 years |
0 0.0%
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
Female |
1 100.0%
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Male |
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
Hispanic or Latino |
0 0.0%
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Not Hispanic or Latino |
1 100.0%
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Unknown or Not Reported |
0 0.0%
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Race (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 1 participants | |
American Indian or Alaska Native |
0 0.0%
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Asian |
0 0.0%
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Native Hawaiian or Other Pacific Islander |
0 0.0%
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Black or African American |
0 0.0%
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White |
1 100.0%
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More than one race |
0 0.0%
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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 | 1 participants |
1 |
Name/Title: | Javier Bolaños Meade, MD |
Organization: | The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Phone: | 410-614-6398 |
EMail: | fbolano2@jhmi.edu |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT02080195 |
Other Study ID Numbers: |
J13134 NA_00082453 ( Other Identifier: Johns Hopkins IRB ) |
First Submitted: | February 28, 2014 |
First Posted: | March 6, 2014 |
Results First Submitted: | September 6, 2018 |
Results First Posted: | October 2, 2018 |
Last Update Posted: | October 2, 2019 |