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Mozobil for Autologous Hematopoietic Stem Cell Transplantation
A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 treatmentAbout the study
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.
What is being tested
- Plerixafor (drug)
- Gcsf (drug)
Sponsor: Thomas Jefferson University · Participants: 100 · Started: Oct 16, 2025
Contact the study team
- Xia Bi, MD, MS · Phone: 215-955-8874
Official record on ClinicalTrials.gov — NCT07188090
Locations in the U.S.
| Pennsylvania | Thomas Jefferson University Hospital, Philadelphia |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.