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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT02080195
Date of registration: 28/02/2014
Prospective Registration: Yes
Primary sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Public title: Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)
Scientific title: A Phase I/II Study of Nonmyeloablative Conditioning and Transplantation of Human Leukocyte Antigen (HLA)-Matched, Partially HLA-mismatched, HLA-haploidentical or Matched Unrelated Bone Marrow for Patients With Refractory SLE
Date of first enrolment: September 13, 2016
Target sample size: 1
Recruitment status: Terminated
Study type:  Interventional
Study design:  Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
United States
Name:     Javier BolaƱos-Meade, MD
Affiliation:  The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Key inclusion & exclusion criteria

Inclusion Criteria:

- Four or more American College of Rheumatology (ACR) criteria for the classification of
SLE or 4 or more of the SLICE criteria

- Involvement of one or more of the following organ systems: renal, neurologic,
hematologic, cardiac, pulmonary, gastrointestinal

- A lack of response to corticosteroids in moderate-to-high doses, and to either an
equivalent degree of immunosuppression with azathioprine, methotrexate, cyclosporin,
tacrolimus, belimumab, rituximab, mycophenolate mofetil, and/or appropriate other

- Patients should be eligible for transplantation according to the BMT Policy Manual

Exclusion Criteria:

- Age less than 18 years and over 75 years

- Any risk of pregnancy

- Patients who are preterminal or moribund

Age minimum: 18 Years
Age maximum: 75 Years
Gender: All
Health Condition(s) or Problem(s) studied
Graft-versus-host Disease
Lupus Erythematosus
Biological: Allogeneic bone marrow transplant
Drug: Cyclophosphamide
Drug: Fludarabine
Drug: Mycophenolate Mofetil
Drug: Rabbit antithymocyte globulin
Drug: Tacrolimus
Radiation: Total body irradiation
Primary Outcome(s)
The Feasibility of the Conditioning Regimen and Post Transplantation Cyclophosphamide in Refractory SLE Patients With Donors Having Various Degrees of Matching [Time Frame: 1 year]
Secondary Outcome(s)
Acute Graft Versus Host Disease (GVHD) [Time Frame: Up to 2 years]
Chronic Graft Versus Host Disease (GVHD) [Time Frame: Up to 2 years]
Graft Failure [Time Frame: 60 days]
RIFLE Score [Time Frame: 1 year]
Survival [Time Frame: 1 year]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Maryland Stem Cell Research Fund
Ethics review
Results available: Yes
Date Posted: 02/10/2018
Date Completed:
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