High-dose Cyclophosphamide for Moderate to Severe Refractory Chronic Inflammatory Demyelinating Polyneuropathy

• Status: Withdrawn
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary endpoint of this study is to determine what percentage of patients receiving high-dose Cyclophosphamide may experience a halt in the worsening of their disease or experience improvement of their disease and for how long the benefit may last.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stony Brook University
• Treatments: Cyclophosphamide

Criteria

Inclusion Criteria:

• Diagnosis of CIDP according to the American Academy of Neurology clinical and electrophysiologic criteria

• Age >18 but < 75 years

• Modified Rankin Scale score of >3 after two standard treatment regimens

• Patient must have a left ventricular ejection fraction of >45%

• Serum Creatinine <3mg/dL

• Willingness to participate in a clinical trial

Exclusion Criteria:

• Patients who are preterminal or moribund

• Patients with active malignancies

• Patients with chromosomal abnormalities or peripheral blood counts suggestive of myelodysplastic syndrome

• Patients with active bacterial or fungal infections requiring oral or intravenous antimicrobials are not eligible until resolution of the infection

• Pregnant women and breast-feeding women