NCT00271934

Brief Summary

In patients with systemic lupus erythematosus, immunosuppressive therapy to the point of complete immune ablation and hematopoietic stem cell recovery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2002

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2002

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

5.2 years

First QC Date

January 2, 2006

Last Update Submit

November 7, 2023

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

  • SLEDAI

    5 years after transplant

Interventions

Immune ablation and hematopoietic stem cell support.BIOLOGICAL

Autologous hematopoietic stem cell transplant

Eligibility Criteria

AgeUp to 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Less than age of 60 year at the time of pretransplant evaluation.
  • An established clinical diagnosis of systemic lupus erythematosus with one of the following features:
  • Lupus nephritis-WHO class III or IV (or V when coexistent III or IV) lupus nephritis, failing NIH short course cyclophosphamide therapy (10mg/kg q month for 6 months). Failure will be defined as failure of creatinine to return to normal or pre-exacerbation level.
  • Vasculitis/Immune complex deposition- causing end organ signs or symptoms e.g. cerebritis, transverse myelitis, pulmonary hemorrhage, cardiac failure, renal failure.
  • Cytopenias that are immune-mediated and not controlled by conservative measures including danzole, prednisone, and alkylating agents (cyclophosphamide or vincristine); and any one of the following: transfusion dependant anemia with untransfused hemoglobin less than 8 grams/dl, or platelets less than 40,000/ul without transfusions,or granulocytes less than 1000/ul.
  • Catastrophic Anti-phospholipid Syndrome
  • \. Ability and willingness to provide informed consent.

You may not qualify if:

  • Human immunodeficiency virus (HIV)positive status.
  • History of unstable angina.
  • Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive chemoradiotherapy.
  • Prior history of malignancy except for localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as head and neck cancer, or stage I breast cancer will be considered on an individual basis.
  • Positive serum pregnancy test, inability or unwillingness to pursue effective means of birth control or failure to willingly accept or comprehend irreversible sterility as a side effect of therapy.
  • Psychiatric illness or mental deficiency not due to active lupus cerebritis making compliance with treatment or informed consent impossible.
  • FEV1/FVC\<50% of predicted, DLCO \<50%of predicted.
  • Resting left ventricular ejection fraction(LVEF)\<35% or lupus induced myocarditis.
  • Known hypersensitivity to Escherichia coli.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University, feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

  • Burt RK, Traynor A, Statkute L, Barr WG, Rosa R, Schroeder J, Verda L, Krosnjar N, Quigley K, Yaung K, Villa Bs M, Takahashi M, Jovanovic B, Oyama Y. Nonmyeloablative hematopoietic stem cell transplantation for systemic lupus erythematosus. JAMA. 2006 Feb 1;295(5):527-35. doi: 10.1001/jama.295.5.527.

    PMID: 16449618RESULT

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Richard Burt, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2006

First Posted

January 4, 2006

Study Start

September 1, 2002

Primary Completion

November 1, 2007

Study Completion

April 1, 2012

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

US(1)