A Prospective Trial Evaluating Plerixafor-based Mobilization and Risk of Engraftment Syndrome After Autologous Hematopoietic Stem Cell Transplantation (HSCT)

NCT07188090 Phase 2 RECRUITING

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.

Details

Lead sponsor	Thomas Jefferson University
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2025-10-16
Completion	2028-06

Conditions

• Multiple Myeloma
• Hodgkin Lymphoma
• Non-hodgkin Lymphoma

Interventions

• Plerixafor
• Gcsf

Primary outcomes

• Incidence of Engraftment Syndrome — 60 days post-autologous stem cell transplant
  ES will be defined as per Maiolino criteria (1) as a new fever \>100.4 F without clinical or microbiological documentation of infection plus at least 1 other criteria: (1) skin rash, (2) pulmonary infiltrates in the absence of cardiac failure, pulmonary embolism, or infection, or (3) 2 or more episodes of diarrhea a day. Clinical signs of ES have to occur within 24 hours before or after the first appearance of neutrophils in the peripheral blood.

Countries

United States