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Mozobil for Autologous Hematopoietic Stem Cell Transplantation

RecruitingPhase 2Ages 18 Years - anyAllThomas Jefferson University
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals must meet all of the following inclusion criteria in order to be eligible to participate in the study: * Age โ‰ฅ18 years * Undergoing autologous stem cell transplant for one of the following diagnoses: * Multiple myeloma * Hodgkin's lymphoma * Non-Hodgkin lymphoma * Karnofsky performance status of โ‰ฅ 60% * Patients must meet the TJUH BMT SOP guidelines for "Patient Criteria for Autologous HSCT" as specified below * Adequate organ function: * LVEF of โ‰ฅ40% * Adjusted DLCO โ‰ฅ45% 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 โ‰ค 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
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What it tests

  • Plerixafor
  • Gcsf
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Where

1 site
Thomas Jefferson University Hospital
Philadelphia, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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