Nonmyeloablative Conditioning and Transplantation for Patients With Refractory Systemic Lupus Erythematosus (SLE)

• Register: ClinicalTrials.gov
• 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
• URL: https://clinicaltrials.gov/show/NCT02080195
• 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

Contacts

• Name: Javier Bolaños-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
treatment

- 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

Lupus Erythematosus

Graft-versus-host Disease

Intervention(s)

Drug: Rabbit antithymocyte globulin

Biological: Allogeneic bone marrow transplant

Drug: Mycophenolate Mofetil

Drug: Tacrolimus

Radiation: Total body irradiation

Drug: Cyclophosphamide

Drug: Fludarabine

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)

RIFLE Score [Time Frame: 1 year]

Graft Failure [Time Frame: 60 days]

Survival [Time Frame: 1 year]

Chronic Graft Versus Host Disease (GVHD) [Time Frame: Up to 2 years]

Acute Graft Versus Host Disease (GVHD) [Time Frame: Up to 2 years]

Secondary ID(s)

J13134

NA_00082453

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Maryland Stem Cell Research Fund

Results

• Results available: Yes
• Date Posted: 02/10/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02080195