An Open-Label Trial of Alemtuzumab in Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIPD)
1. Signed informed consent form (ICF).
2. Men or women aged ≥18 years as of the date the ICF is signed.
3. Diagnosis of CIDP made by a consultant neurologist with a special interest in
peripheral neuropathy. CIDP may be diagnosed in the presence of diabetes or
IgG(immunoglobulin- G), IgA and IgM paraproteins without anti- MAG (myelin associated
glycoprotein) antibodies. Documentation of the initial diagnosis including definite
neurophysiological criteria proposed by INCAT (lnflammatory Neuropathy Cause and
Treatment) or EFNS/PNS (European Federation of Neuroscience/Peripheral Nerve Society)
must be available for review.
4. Ongoing treatment(s) for CIDP to include IVIg (Intravenous immune globulin) or
corticosteroids only. Other treatments for CIDP including plasma exchange,
azathioprine, methotrexate and mycophenolate must be washed out for 3 months.
Cyclophosphamide, rituximab and other monoclonal antibodies must be washed out for 12
5. Duration of CIDP > 6 months prior to the date the ICF is signed.
6. Treating neurologist and participant in agreement that alemtuzumab is an appropriate
treatment and documents this is in clinical notes.
1. Previous treatment with alemtuzumab.
2. Participation in a controlled trial of an investigational medicinal product within
the past 12 weeks. The duration of required washout will be established based on the
known biological and pharmacokinetic properties of the investigational drug (prior
treatment with herbal medications or nutritional supplements is permitted).
3. Intolerance of pulsed corticosteroids.
4. Alternative cause of peripheral neuropathy such as drug or toxin, hereditary
neuropathy or concomitant diseases such as HIV infection, Lyme disease, chronic
active hepatitis, systemic lupus erythematosus, IgM paraprotein with anti-MAG (myelin
associated glycoprotein) antibodies, vasculitis, thyroid dysfunction, hematological
and non- hematological malignancies.
5. Presence of neurogenic sphincter disturbance.
6. Multifocal motor neuropathy (fulfilling EFNS/PNS (European Federation of
Neuroscience/Peripheral Nerve Society) criteria).
7. Atypical CIDP with pure sensory or persistent uni-focal impairment or significant CNS
8. Active infection, e.g., deep-tissue infection that the Investigator considers
sufficiently serious to preclude study participation.
9. In the Investigator's opinion, is at high risk for infection (e.g., in-dwelling
catheter, dysphagia, decubitus ulcer, history of prior aspiration pneumonia or
recurrent urinary tract infection).
10. Known infection with or seropositivity for human immunodeficiency virus (HIV).
11. Previous or present infection with hepatitis C virus.
12. Previous or present infection with hepatitis B (positive hepatitis B serology).
13. Prior history of invasive fungal infections.
14. Latent tuberculosis, unless effective anti-tuberculosis therapy has been completed,
or active tuberculosis
15. Cervical high risk human papillomavirus (HPV) positivity or abnormal cervical
cytology other than abnormal squamous cells of undetermined significance (ASCUS). The
participant may be eligible after the condition has resolved (e.g., follow-up HPV
(human papilloma virus) test is negative or cervical abnormality has been effectively
16. CD4+ (cluster of differentiation - 4), CD8+ , or CD19+ cell count (i.e., absolute
CD3+CD4+, CD3+CD8+, or CD19+/mm3) cell count
Screening. If abnormal cell counts return to within normal limits, eligibility may be
17. Absolute neutrophil count below the LLN at screening. If abnormal cell counts return
to with in normal limits, eligibility may be reassessed.
18. Confirmed platelet count
at <100,000/μL within the past year on a sample without platelet clumping.
19. Known bleeding disorder (e.g.,dysfibrinogenemia, factor IX deficiency, hemophilia,
vonWillebrand's disease, disseminated intravascular coagulation (DIC), fibrinogen
deficiency, clotting factor deficiency) or chronic use of anticoagulant treatment.
20. Significant other active autoimmune disease, besides CIDP (e.g., immune cytopenias,
rheumatoid arthritis, systemic lupus erythematosus, other connective tissue
disorders, vasculitis, inflammatory bowel disease, severe psoriasis, thyroiditis).
21. Presence of anti-thyroid stimulating hormone (TSH) receptor (TSHR) antibodies (i.e.,
22. History of malignancy (exception for basal cell skin carcinoma).
23. Major psychiatric disorder not adequately controlled by treatment.
24. History of substance abuse within the last 2 years.
25. Epileptic seizures not adequately controlled by treatment.
26. Of child bearing potential with a positive serum pregnancy test,pregnant,or
27. Unwilling to agree to use a reliable and acceptable contraceptive method throughout
the study period (all participants of reproductive potential). Reliable and effective
contraceptive method(s) include: intrauterine device (IUD), hormonal-based
contraception, surgical sterilization, abstinence, or double- barrier contraception
(condom and occlusive cap [diaphragm or cervical cap with spermicide]).
28. Any hepatorenal function value grade 2 or higher at screening (see Table below, drawn
from the National Cancer Institute (NCI) Common Terminology Criteria for Adverse
Events v3.0 (CTCAE), released 12 December 2003), with the exception of
hyperbilirubinemia due to Gilbert's syndrome:
Hepatic Bilirubin >1.5x ULN (upper limit of normal) SGOT/AST
>2.5x ULN SGPT/ALT >2.5x ULN Alkaline phosphatase
Renal Creatinine >1.5x ULN
29. Other conditions that,in the Investigator's opinion,compromise the participant's
ability to understand the participant information, to give informed consent, to
comply with the trial protocol, or to complete the study.
30. Immunocompromise of any type which would in the view of the investigator make the
risk of alemtuzumab treatment unacceptable.
31. Previous stem cell transplantation.