Recruiting
Phase 2

G-CSF with Plerixafor

Sponsor:

Thomas Jefferson University

Code:

NCT07188090

Conditions

Multiple Myeloma

Hodgkin Lymphoma

Non-hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Plerixafor

Gcsf

Study Details

Brief 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.

Conditions

Multiple Myeloma

Hodgkin Lymphoma

Non-hodgkin Lymphoma

Study ID

NCT07188090

Start date

Oct 16, 2025

Status verified date

Nov, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment with G-CSF and plerixafor for stem cell mobilization

All patients will receive G-CSF (peg-filgrastim or filgrastim) on day -4 prior to planned peripheral blood stem cell (PBSC) collection day 0. All patients will proceed with stem cell collection on day 0. If less than 1.7 x 106 CD34+ cells/kg is collected after the first day or the target number of stem cells is not collected after two days, Plerixafor will be administered, and additional collection days will be added until the collection goal is reached.

Interventions

Plerixafor

Plerixafor is an antagonist of chemokine receptor-4 (CXCR4) receptor that can release stem cells from the bone marrow niche into the peripheral blood circulation

Gcsf

All patients will receive G-CSF (peg-filgrastim or filgrastim) starting on day -4, prior to planned peripheral blood stem cell collection on day 0.

Primary outcome measure

  • Incidence of Engraftment Syndrome [ Time Frame: 60 days post-autologous stem cell transplant ]

Central Contacts and Locations

Central contacts

Xia Bi, MD, MS

215-955-8874Xia.Bi@jefferson.edu

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Xia Bi, MD, MS

215-955-8874Xia.Bi@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Nov 28, 2025

Last verified

Nov, 2025

Keywords

  • Engraftment syndrome
  • stem cell mobilization
  • autologous stem cell transplant
  • Plerixafor
  • G-CSF

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2025-11-28.