Last updated on October 2020

A Phase I Study of Mozobil in the Treatment of Patients With WHIMS


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: WHIMS | Neutrophil Disorder | White Cell Disorders | Warts | Leukopenia | Infection | Myelokathexis | Hypogammaglobulinemia | Verruca vulgaris | White blood cell disorder | Neutropenia
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

  • INCLUSION CRITERIA:

All of the following inclusion criteria must be met for a subject to be enrolled in this

study
  • Clinical diagnosis of WHIMS and documented severe infection
  • Must be greater than or equal to 18 and less than or equal to 75 years of age
  • Willingness to interrupt medications to raise the white count (WBC) such as G-CSF or GM-CSF for at least 2 days before and while on the study drug
  • Must not be pregnant or breastfeeding
  • Must have a personal physician
  • Must be willing to provide blood, plasma, serum, and DNA samples for storage
  • Subjects must agree not to become pregnant or to impregnate a female. If of childbearing potential, must agree to consistently use two types of contraception throughout study participation. Acceptable forms of contraception include the
following
  1. Condoms, male or female, with or without a spermicide
  2. Diaphragm or cervical cap with spermicide
  3. Intrauterine device
  4. Contraceptive pills or patch, Norplant, Depo-Provera or other FDA-approved contraceptive method
  5. Male partner has previously undergone a vasectomy for which there is documentation of aspermatogenic sterility

EXCLUSION CRITERIA:

If any of the following exclusion criteria are met, a subject will not be enrolled in this

study
  • Absence of a diagnosis of WHIMS
  • Patient is less than 18 years old
  • Absence of a documented history of severe infection
  • Neutropenia due to maturation defects in the myeloid lineage or that the PI feels is unlikely to benefit from this medication
  • Pregnant women or breastfeeding
  • History of serious cardiac arrhythmia or cardiac defects that make such more likely
  • Renal failure (calculated creatinine clearance [CrCl] <15 mL/min or requiring dialysis)
  • Signs or symptoms of active microbial infection at the time of study entry.
  • Any condition that, in the investigator s opinion, places the patient at undue risk by participating in the study
  • Unwillingness to undergo testing or procedures associated with this protocol

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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