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Sponsored by: |
Northwestern University |
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Information provided by: | Northwestern University |
ClinicalTrials.gov Identifier: | NCT00278629 |
Chronic inflammatory demyelinating polyneuropathy is disease believed to be due to immune cells, cells which normally protect the body, but are now attacking the nerves in the body. As a result, the affected nerves fail to respond, or respond only weakly, to stimuli causing numbing, tingling, pain, and progressive muscle weakness. The likelihood of progression of the disease is high. This study is designed to examine whether treating patients with high dose cyclophosphamide (a drug which reduces the function of the immune system) and ATG (a protein that kills the immune cells that are thought to be causing your disease), followed by return of the previously collected blood stem cells will stop the progression of CIDP. Stem cells are undeveloped cells that have the capacity to grow into mature blood cells, which normally circulate in the blood stream. The purpose of the high dose cyclophosphamide and ATG is to destroy the cells in the immune system. The purpose of the stem cell infusion is to evaluate whether this treatment will produce a normal immune system that will no longer attack the body.
Condition | Intervention | Phase |
---|---|---|
Polyneuropathy |
Procedure: hematopoietic stem cell transplantation |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | High Dose Cyclophosphamide & ATG With Hematopoietic Stem Cell Support in Patients With Chronic Inflammatory Demyelinating Polyneuropathy: A Phase I Trial |
Estimated Enrollment: | 10 |
Study Start Date: | March 2005 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | up to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Failure to therapy defined by (one of the following) (not caused by unrelated conditions):
Exclusion Criteria:
1. Any evidence of another cause for neuropathy.
2. Nerve pathology (if available) not consistent with CIDP.
3. Poor performance (PS) status (ECOG >2) at the time of entry, unless decline of PS is due to the disease itself.
4. Significant end organ damage such as (not caused by CIDP):
Liver cirrhosis, transaminases >3x of normal limits or bilirubin >2.0 unless due to Gilbert disease.
5. HIV positive.
6. Uncontrolled diabetes mellitus, or any other illness that in the opinion of the investigators would jeopardize the ability of the patient to tolerate aggressive treatment.
7. Prior history of malignancy except localized basal cell or squamous skin cancer. Other malignancies for which the patient is judged to be cured by local surgical therapy, such as (but not limited to) head and neck cancer, or stage I or II breast cancer will be considered on an individual basis.
8. Positive 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.
9. Psychiatric illness or mental deficiency making compliance with treatment or informed consent impossible.
10. Inability to give informed consent.
11. Major hematological abnormalities such as platelet count less than 100,000/ul or ANC less than 1000/ul.
12. Failure to collect at least 2.0 x 106 CD34+ cells by apheresis and, if necessary, bone marrow harvest is a contraindication to treatment, i.e., receiving the conditioning regimen.
Contact: Dzemila Spahovic, MD | 312-908-0059 | d-spahovic@northwestern.edu |
United States, Illinois | |
Northwestern University, Feinberg School of Medicine | Recruiting |
Chicago, Illinois, United States, 60611 | |
Principal Investigator: Richard Burt, MD | |
Sub-Investigator: Kathleen Quigley, R.N.;MBA | |
Sub-Investigator: Kimberly Yaung, R.N. | |
Principal Investigator: Robert Sufit Sufit, MD |
Principal Investigator: | Richard Burt, MD | Northwestern University |
Responsible Party: | Northwestern University ( Robert Craig, MD ) |
Study ID Numbers: | NU FDA CIDP.AUTO2003 |
Study First Received: | January 16, 2006 |
Last Updated: | November 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00278629 |
Health Authority: | United States: Food and Drug Administration |
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating Autoimmune Diseases Demyelinating Diseases Neuromuscular Diseases Polyradiculoneuropathy Peripheral Nervous System Diseases |
Polyneuropathies Demyelinating diseases Cyclophosphamide Chronic inflammatory demyelinating polyneuropathy Autoimmune Diseases of the Nervous System |
Immune System Diseases Nervous System Diseases |