Mozobil for Autologous Hematopoietic Stem Cell Transplantation

NCT07188090 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: iRISID-2024-1641JT 44251
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Incidence of Engraftment Syndrome

  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.

  60 days post-autologous stem cell transplant

Secondary Outcomes (10)

• Efficacy of Stem Cell Mobilization

  30 days post-autologous stem cell transplant

• Time to Neutrophil Engraftment

  Up to 90 days post-transplant

• Time to Platelet Engraftment

  Up to 90 days post-transplant

• Number of Collection Days

  Up to 90 days post-transplant

• Length of Hospital Stay

  Up to 90 days post-transplant

Study Arms (1)

Treatment with G-CSF and plerixafor for stem cell mobilization

EXPERIMENTAL

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.

Drug: Plerixafor; Drug: Gcsf

Interventions

Plerixafor DRUG

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

Also known as: Mozobil

Treatment with G-CSF and plerixafor for stem cell mobilization

Gcsf DRUG

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.

Also known as: peg-filgrastim, filgrastim

Treatment with G-CSF and plerixafor for stem cell mobilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Multiple Myeloma; Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

plerixafor; Granulocyte Colony-Stimulating Factor; pegfilgrastim; Filgrastim

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Lymphoma; Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xia Bi, MD, MS

  Xia.Bi@jefferson.edu

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xia Bi, MD, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 23, 2025
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

US (1)