Mozobil (plerixafor) to mobilize stem cells for autologous transplant

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single‑arm, open‑label trial using G‑CSF as the primary mobilizing agent with risk‑adapted use of Plerixafor. Patients start G‑CSF (peg‑filgrastim or filgrastim) before planned collection and undergo apheresis on day 0 with a target of about 3 x 10^6 CD34+ cells/kg. Plerixafor is given only if collection yields are <1.7 x 10^6 CD34+ cells/kg after the first day or if targets are not met after two days; pre‑collection peripheral CD34+ counts are measured but not used to trigger Plerixafor. The study measures incidence of engraftment syndrome and stem cell collection success compared with historical rates.

Why it matters

Who can join: the full rules

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

Where it's running

• Thomas Jefferson University Hospital
  Philadelphia, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Xia Bi, MD, MS — Xia.Bi@jefferson.edu
• Study coordinator: Xia Bi, MD, MS
• Email: Xia.Bi@jefferson.edu
• Phone: 215-955-8874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.