Study on Using Mozobil for Stem Cell Transplantation
Sponsor: Thomas Jefferson University
ClinicalTrials ID:NCT07188090
This clinical trial is exploring a new approach to collecting stem cells for transplantation in patients with certain types of cancer. The study aims to see if using a medication called G-CSF alone, with selective use of another drug, Plerixafor, can effectively collect stem cells while reducing side effects.
Patient Parameters
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Program Overview
The purpose of this study is to find out if using G-CSF alone, with Plerixafor only when needed, can successfully collect enough stem cells for transplantation in patients with multiple myeloma or lymphoma. The study also aims to see if this approach can lower the risk of engraftment syndrome, a condition that can occur after stem cell transplantation and cause symptoms like fever and rash.
Description
This clinical trial is testing a new method for collecting stem cells in patients undergoing autologous stem cell transplantation. The study will use G-CSF as the main drug to help move stem cells from the bone marrow into the bloodstream, where they can be collected. Plerixafor will be used only if necessary to help collect enough stem cells.
All participants will receive G-CSF starting four days before the planned stem cell collection. The collection will be done through a process called apheresis, which involves drawing blood, separating out the stem cells, and returning the rest of the blood to the body. If the initial collection does not yield enough stem cells, Plerixafor will be given, and additional collection days will be scheduled.
The main goal of the study is to see how often engraftment syndrome occurs in patients who do and do not receive Plerixafor. Other goals include evaluating how well the stem cell collection works, how quickly blood counts recover after transplantation, and the overall response to treatment. Participants will be closely monitored with regular blood tests and other assessments to track their progress and any side effects.
The study will also analyze the types of cells collected and measure certain proteins in the blood to better understand the development of engraftment syndrome. This research aims to improve the safety and effectiveness of stem cell transplantation by potentially reducing complications while ensuring enough stem cells are collected for successful treatment.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Undergoing autologous stem cell transplant for multiple myeloma, Hodgkin's lymphoma, or Non-Hodgkin lymphoma.
- Have a performance status score of 60% or higher, indicating the ability to carry out daily activities.
- Meet specific health criteria, including adequate heart, lung, liver, and kidney function.
- Willing to use contraception if there is a potential for childbearing.
- Able to provide informed consent or have a family member or guardian assist in the consent process.
- Have a life expectancy of more than 12 months, excluding the disease being treated.
- Have previously undergone stem cell mobilization with G-CSF, with or without Plerixafor.
Exclusion Criteria
- Uncontrolled HIV infection.
- Uncontrolled bacterial infection.
- Active disease affecting the central nervous system.
- Pregnant or breastfeeding.
- Have another type of cancer, except for certain skin cancers that only require local treatment.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Thomas Jefferson University Hospital | 19107 | Philadelphia | Pennsylvania |
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