Nonmyeloablative Allo Stem Cell Transplant for Severe Autoimmune Diseases

Stopped early · Phase 1

Conditions studied: Systemic Lupus Erythematosus, Systemic Sclerosis

In brief

Autoimmune diseases present a special challenge to clinicians and the aim of this protocol is to serve as a last-line effort for patients with unmanageable disease. The primary purpose of this study is to assess feasibility in terms of toxicity and engraftment of a less toxic, nonablative conditioning regimen of Campath-1H, moderate dose fludarabine, and cyclophosphamide for patients with severe autoimmune diseases.

Key facts

Study ID

NCT00849745

Run by

Duke University

People needed

4

Starts

2003-01-01

Expected to finish

2015-07-01

Last updated by the study team

2016-06-23

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Pregnant or lactating women
• Active uncontrolled infection
• Patients who are serologically true-positive for HIV
• Patients with other major medical or psychiatric illnesses, which the treating physician feels, could seriously compromise tolerance to this protocol
• Uncontrolled hypertension (BP > 100 diastolic despite treatment with maximum doses of at least 3 simultaneous or concurrent antihypertensives over a 2-month period)
• Uncontrolled malignant arrythmias or clinical evidence of congestive heart failure (New York Class IV)
• 6/6 HLA-Matched Related PBSC Donor Inclusion/Exclusion Criteria:
• Adult donors must be capable of providing informed consent; Potential donors under the age of 18 must have a 'single patient exemption' approved by the IRB and the donor and a guardian must provide assent.
• Donor must be 6/6 HLA matched, and related to the patient.
• Donor must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:
• Adequate cardiac function by history and physical examination. Those with a history of cardiac problems should undergo a stress evaluation or be evaluated by a cardiologist and deemed eligible to donate.
• bilirubin and hepatic transaminases < or equal to 2.5 x ULN,
• adequate hematologic parameters including a hematocrit > 35% for males and 33% for females, white blood cell count of > or equal to 3,000, and platelets > or equal to 80,000.
• Donors with a known allergy to E. coli-derived products are ineligible for mobilization with G-CSF.
• Females of childbearing potential should have a negative serum beta-HCG test within 1 week of beginning G-CSF.

Where it is running

• Duke University Health System — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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