NCT07188090RecruitingPhase 2
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
Source: ClinicalTrials.gov · Last updated 28 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 15 Sept 2025
- Start date
- 16 Oct 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- Thomas Jefferson University
- Diseases
- Hodgkin lymphoma, Multiple myeloma
- NCT number
- NCT07188090
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 100
- From 16 Oct 2025 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.