Mozobil (plerixafor) to mobilize stem cells for autologous transplant
A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
This trial will test whether starting with G‑CSF and giving Plerixafor only when needed can collect enough stem cells for adults with multiple myeloma or lymphoma undergoing autologous transplant while possibly lowering engraftment syndrome.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07188090 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (≥18) with multiple myeloma, Hodgkin lymphoma, or non‑Hodgkin lymphoma planned for autologous HSCT who have Karnofsky ≥60% and meet the study's organ‑function and institutional HSCT criteria.
Not a fit: Patients who are known poor mobilizers, who require immediate or routine upfront Plerixafor, or who do not meet performance status or organ‑function eligibility are unlikely to benefit from this approach.
Why it matters
Potential benefit: If successful, this approach could reduce engraftment syndrome while still achieving adequate stem cell collection, making mobilization safer and simpler for patients.
How similar studies have performed: Combining G‑CSF and plerixafor is established to improve stem cell yield, but prospective data on a risk‑adapted strategy specifically aimed at reducing engraftment syndrome are limited.
Eligibility criteria
Show full inclusion / exclusion 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 treatment
Where this trial is running
Philadelphia, Pennsylvania
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.