Plerixafor + G-CSF for Stem Cell Mobilization

(HSCT Trial)

Overseen By Xia Bi, MD, MS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Thomas Jefferson University

Must be taking: G-CSF, Plerixafor

Disqualifiers: Uncontrolled HIV, Active CNS disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for collecting stem cells in patients with multiple myeloma or certain types of lymphoma undergoing autologous stem cell transplants. The researchers aim to determine if using G-CSF, a growth factor that increases blood stem cell production, along with selective use of Plerixafor, a drug that moves stem cells from the bone marrow into the blood, can effectively gather enough stem cells while reducing the risk of engraftment syndrome, a condition where new cells cause inflammation. Suitable candidates for this trial have one of the qualifying conditions and are already scheduled for a transplant using their own stem cells. Participants must have previously attempted stem cell mobilization with G-CSF, with or without Plerixafor. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using Plerixafor with G-CSF is safe for many patients. A large study found that this combination effectively helps the body produce and release stem cells into the blood and is generally well-tolerated. Another study confirmed its safety for patients with certain blood cancers.

However, there is a risk of developing engraftment syndrome, a reaction to the new cells. This trial tests whether starting with G-CSF alone and adding Plerixafor only if needed can still provide enough stem cells while reducing this risk.

Overall, Plerixafor and G-CSF have been used safely in the past, but this trial seeks to improve their use by altering their combination. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Plerixafor + G-CSF because this combination offers a new way to boost stem cell mobilization, which is crucial for successful stem cell transplants. While G-CSF (a growth factor stimulating white blood cell production) is a standard treatment, adding Plerixafor helps release more stem cells into the bloodstream. This means patients who don't initially collect enough stem cells can potentially reach the desired levels faster and more efficiently. This approach could lead to better outcomes for those needing stem cell transplants.

What evidence suggests that this trial's treatments could be effective for stem cell mobilization?

Studies have shown that using both Plerixafor and G-CSF together collects more stem cells than using G-CSF alone. This combination helps more patients reach their stem cell targets, which is crucial for successful transplants. Plerixafor proves especially helpful for those who struggle to collect enough stem cells with just G-CSF. Research also indicates that this method works well for patients with blood cancers like multiple myeloma and lymphoma. However, there is a risk of engraftment syndrome, where the body reacts to the new stem cells. In this trial, all participants will initially receive G-CSF, with Plerixafor added only if necessary, to explore whether this approach can lower the risk of engraftment syndrome while still collecting enough stem cells. ^{1 6 7 8 9}

Who Is on the Research Team?

Xia Bi, MD, MS

Principal Investigator

[e-mail]

Are You a Good Fit for This Trial?

This trial is for adults over 18 with Hodgkin's lymphoma, multiple myeloma, or non-Hodgkin lymphoma. They must have a Karnofsky performance status of at least 60%, good liver function (bilirubin <1.8 and AST/ALT <2.5 times the normal limit), heart function (LVEF ≥40%), and lung capacity (adjusted DLCO ≥45%). Kidney function should be adequate with serum creatinine ≤2.0 mg/dl or clearance >40 ml/min.

Inclusion Criteria

Patients must meet the TJUH BMT SOP guidelines for 'Patient Criteria for Autologous HSCT'

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

Exclusion Criteria

Pregnancy or lactation

My HIV is not under control.

I do not have an untreated bacterial infection.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mobilization and Collection

Participants receive G-CSF starting on day -4, followed by stem cell collection on day 0. Plerixafor is administered if necessary to achieve target stem cell count.

Up to 2 weeks

Daily visits for collection and monitoring

Transplantation

Autologous stem cell transplantation is performed after successful mobilization and collection of stem cells.

1 week

Inpatient stay for transplantation

Follow-up

Participants are monitored for safety and effectiveness after transplantation, including engraftment and disease response.

90 days

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• G-CSF
• Plerixafor

Trial Overview The study tests if using G-CSF alone, with Plerixafor added only when needed, can effectively mobilize stem cells for transplantation in patients while reducing engraftment syndrome risks compared to the standard combined use since FDA approval in 2008.

How Is the Trial Designed?

Group I: Treatment with G-CSF and plerixafor for stem cell mobilization Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Thomas Jefferson University

Lead Sponsor

Trials

475

Recruited

189,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10939106/

G-CSF + plerixafor versus G-CSF alone mobilized ... This study suggests that the combination of G-CSF and plerixafor, resulted in more patients with MM, NHL, and HL, achieving the predetermined apheresis yield ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1936523323001973

An evidence-based and risk-adapted GSF versus GSF plus ... This study aims to evaluate the efficacy of G-CSF plus plerixafor versus G-CSF alone mobilizing regimens on the basis of CD34+ cell yield and engraftment ...

3. astctjournal.org astctjournal.org/article/S1083-8791(15)01466-4/fulltext

Cost and Outcome Analysis of Autologous Peripheral ... Plerixafor (PLX) plus granulocyte-colony stimulating factor (G-CSF) and cyclophosphamide (CY) plus G-CSF are commonly used to mobilize peripheral blood stem ...

4. ashpublications.org ashpublications.org/blood/article/114/22/3229/132963/Plerixafor-Mozobil-R-Plus-G-CSF-Is-Effective-in

Plerixafor (Mozobil ® )Plus G-CSF Is Effective in Mobilizing ... Plerixafor (Mozobil ®)Plus G-CSF Is Effective in Mobilizing Hematopoietic Stem Cells in Patients with Concurrent Thrombocytopenia Undergoing ...

5. nature.com nature.com/articles/s41409-019-0676-0

Results from a multicenter, noninterventional registry study ... Plerixafor plus granulocyte-colony stimulating factor (G-CSF) enhances the mobilization of hematopoietic stem cells (HSCs) for collection ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1473050225000643

Efficiency and safety of granulocyte colony-stimulating ... In this retrospective study, we assessed the safety and efficacy of G-CSF in combination with plerixafor to mobilize AL amyloidosis patients.

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03055247

Combination of Ibuprofen, G-CSF and Plerixafor as Stem ... This is a phase II exploratory study conducted to evaluate the safety and efficacy of the combination of Ibuprofen, G-CSF and Plerixafor as stem cell ...

8. haematologica.org haematologica.org/article/view/6552

Plerixafor and granulocyte colony-stimulating factor for first- ... The primary study objective was to confirm the safety of mobilization with plerixafor in patients with NHL and MM who were eligible to undergo ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8844333/

Safety and Effectiveness of Plerixafor for Peripheral Blood ... This large post-marketing surveillance study demonstrated the safety and effectiveness of plerixafor in combination with G-CSF for stem cell ...