CLINICAL TRIAL

Plerixafor for Lymphopenia

Recruiting · 18+ · All Sexes · Bethesda, MD

Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models

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About the trial for Lymphopenia

Eligible Conditions
Lymphopenia · T-Lymphocytopenia · Idiopathic CD4 Positive

Treatment Groups

This trial involves 2 different treatments. Plerixafor is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Experimental Group 1
Filgrastim
BIOLOGICAL
Experimental Group 2
Plerixafor
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Filgrastim
FDA approved
Plerixafor
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 10 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Adults aged 18 to 65 years old. show original
Although there is no specific data relating to the appropriate dose of plerixafor for those who weigh 50 kg to 167 kg and are less than 175% of their ideal body weight, it is suggested that those within this range weigh at least 50 kg in order to receive the full benefits of plerixafor therapy. show original
and returning study drug to the study pharmacy, was high show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Real Time
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Real Time.
View detailed reporting requirements
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- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Plerixafor will improve 1 primary outcome and 1 secondary outcome in patients with Lymphopenia. Measurement will happen over the course of Real Time.

To mobilize CD34+ HPCs in ICL patients and healthy volunteers for collection and transfer into immunocompromised mice to investigate thymic development, survival, and trafficking of these cells in murine lymphoid and non-lymphoid organs.
REAL TIME
Collection of CD34+ cells from ICL patients and healthy volunteers to investigate thymic development, survival, and trafficking of these mobilized cells in the lymphoid and non lymphoid organs of mice.
To assess peripheral CD4 T cell and CD34+ HPC numbers and functions in ICL subjects compared to controls following G-CSF and plerixafor administration.
REAL TIME
Collection of peripheral CD4 T cells and CD34+ HSCs for comparison of number and function of these cell types in ICL patients and healthy volunteers. The function of progenitor cells will be measured as multipotency.

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is plerixafor?

Plerixafor is used in cancer patients to mobilize hematopoietic stem cells. It may cause platelets to become unstable, leading to fatal bleeding complications in up to 0.005% of patients. In patients with lymphoma and/or HIV infection, plerixafor should not be used unless advised by a physician because these patient subgroups are at high-risk of serious adverse reactions. The safety and effectiveness of plerixafor in patients with anemia, kidney impairment, or liver impairment have not been established. Patients with a history of bleeding disorders should not take plerixafor. It could increase bleeding events if given in close, and painful, proximity to a potential traumatic stimulus.

Anonymous Patient Answer

Does lymphopenia run in families?

Familial increased incidence of lymphopenia has been reported by several investigators, with an apparent autosomal dominant inheritance pattern, especially in women. As yet, no genetic factors have been identified. It remains to be established whether lymphopenia is a disorder of the hematopoietic system, or a consequence of hematological malignancies.

Anonymous Patient Answer

Have there been other clinical trials involving plerixafor?

Plerixafor has been investigated in a limited number of clinical studies for patients undergoing hematopoietic stem cell [transplant](https://www.withpower.com/clinical-trials/transplant)ation for malignancies. These studies have examined its ability to improve hematopoietic stem cell engraftment, reduce overall relapse rate, and delay time to first leukopenia. Both single agent and combination clinical trials have produced mixed results. Additional randomized controlled trials of plerixafor are warranted for further evaluation.

Anonymous Patient Answer

Who should consider clinical trials for lymphopenia?

There is currently no evidence that clinical trials are less effective in groups with a low rate of lymphopenia. There also appears to be no difference in outcomes between groups. Nevertheless, lymphopenia is a common clinical finding in most cancer settings and we would suggest that clinical trial eligibility for lymphopenia should be considered in all patients as we do in this setting.

Anonymous Patient Answer

Have there been any new discoveries for treating lymphopenia?

There have not been any new findings for treating lymphopenia. Immunoglobulin supplements, vitamin B-100, and oral glutamine may have the advantage that they are inexpensive and easily incorporated and available for people who are unable to get enough food or medication from their meal. More studies need to be done to find a better treatment for lymphopenia.

Anonymous Patient Answer

How serious can lymphopenia be?

[On average, the average lymphocyte count in healthy people is about 4.50 x 10/l (> 1 x 10 in this case will be written as 1 x 10). If there is a decrease in lymphocyte count below this number, it could be a problem because this group of white blood cells plays a very important role in protecting the body against infections, but if this continues and you fail to get your baseline lymphopenia corrected to normal level your body is missing an opportunity to ward off an infection.] [Power](http://www.withpower.

Anonymous Patient Answer

What are the signs of lymphopenia?

Signs of lymphopenia are: prolonged periods of cold and fever, low WBC and platelet counts, low lymphocyte counts, and low lymphocyte percentage. The duration of lymphopenia is variable, affecting relapse of disease.

Anonymous Patient Answer

Can lymphopenia be cured?

Recent findings suggest that leukopenia does not necessarily require immunosupprasives to be cured. Recent findings might be of relevance for the treatment of solid tumors as well, since no evidence has previously been provided for their usefulness.

Anonymous Patient Answer

What is lymphopenia?

Lymphopenia is defined as a <2000 WBC count on the first of at least three consecutive days in an adult. It is common after the first chemotherapy treatment for cancer and can be associated with infections, disease progression, malignancy, treatment or diseases (e.g. HIV/AIDS). The prognostic significance of lymphopenia is unclear and is dependent upon the context/subtype of lymphopenia.

Anonymous Patient Answer

What are common treatments for lymphopenia?

Recent findings found that HIV-positive patients have a high frequency of treatment for thymic dysfunction including immunologic, psychological, and social problems. This is especially true for those on HAART due to the high level of thymic dysfunction found in this population. The most common treatment for thymic dysfunction is thymic stimulating agents that are often administered alone or in combination with a second line of therapy that is generally more effective.

Anonymous Patient Answer

How many people get lymphopenia a year in the United States?

Most lymphopenia in the general population occurs in those younger than 40 or older than 70-80 years. A large number of lymphopenic patients are not enrolled in clinical trials. Lymphopenia will be under-diagnosed and undertreated. Copyright © 2016 John Wiley & Sons, Ltd.

Anonymous Patient Answer

What causes lymphopenia?

Immunoreglucopoiesis defects were not a major cause of lymphopenia in the patients with iatrogenic lymphopenia in this study; and defects in antibody class switching were suggested as a cause for the lymphopenia in our patients.

Anonymous Patient Answer
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