Mozobil for Autologous Hematopoietic Stem Cell Transplantation

Summary

This prospective trial investigates the approach of G-CSF with risk-adapted Plerixafor use for stem cell mobilization in patients undergoing autologous stem cell transplantation. Since FDA approval in 2008, Plerixafor has been combined with G-CSF to mobilize stem cells, though this regimen has been associated with a potentially higher incidence of engraftment syndrome. The trial aims to evaluate whether using G-CSF alone, with selective use of Plerixafor, can achieve adequate stem cell collection while possibly reducing the incidence of engraftment syndrome.

Eligibility

Inclusion Criteria:

* Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study:

  * Age ≥18 years
  * Undergoing autologous stem cell transplant for one of the following diagnoses:

    * Multiple myeloma
    * Hodgkin's lymphoma
    * Non-Hodgkin lymphoma
  * Karnofsky performance status of ≥ 60%
  * Patients must meet the TJUH BMT SOP guidelines for "Patient Criteria for Autologous HSCT" as specified below
  * Adequate organ function:

    * LVEF of ≥40%
    * Adjusted DLCO ≥45% of predicted corrected for hemoglobin
  * Adequate liver function as defined by a serum bilirubin \<1.8, AST or ALT \< 2.5X upper limit of normal
  * Serum creatinine ≤ 2.0 mg/dl and/or creatinine clearance of \> 40 ml/min (excludes multiple myeloma patients receiving high dose Melphalan conditioning)
  * Willingness to use contraception if childbearing potential
  * Has the ability to give informed consent, or for cognitively or decisionally impaired individuals (vulnerable population), the availability of a family member or guardian to give consent and assist in the consent process
  * Life expectancy of \> 12 months (exclusive of the disease for which the Auto HSCT is being performed)
  * Patients must have undergone stem cell mobilization with the combination of G- CSF or biosimilars with plerixafor or G-CSF or biosimilars alone

Exclusion Criteria:

* An individual who meets any of the following criteria will be excluded from participation in this study:

  * Uncontrolled HIV
  * Uncontrolled bacterial infection
  * Active CNS disease
  * Pregnancy or lactation
  * Evidence of another malignancy, exclusive of a skin cancer that requires only local treatment

Conditions4

Locations1 site

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