A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation
Thomas Jefferson University
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.
Description
This is a prospective, single-arm, open-label clinical trial designed to evaluate the incidence of engraftment syndrome and the efficacy of using granulocyte colonystimulating factor (G-CSF) as the primary agent for stem cell mobilization in patients undergoing autologous stem cell transplantation. The study aims to determine whether selective use of Plerixafor, administered only when necessary, can reduce the incidence of engraftment syndrome compared to a historical rate of 54%, where seventy patients with multiple myeloma or lymphoma were treated with autologous HSCT after stem cell mobiliz…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 live…
Interventions
- DrugPlerixafor
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
- DrugGcsf
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.
Location
- Thomas Jefferson University HospitalPhiladelphia, Pennsylvania