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RECRUITINGPhase 2INTERVENTIONAL

Mozobil for Autologous Hematopoietic Stem Cell Transplantation

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 - your organs (liver, kidneys, etc.) are working well enough based on blood tests: - 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 willing to sign a consent form, 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

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

DRUG

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.

Locations (1)

Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States