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Growth Factor

Stem Cell Mobilization for T Cell Lymphocytopenia

Q: How many individuals are eligible to join this research?

Affirmative. Clinicaltrials.gov confirms that this medical research is actively seeking volunteers, with the posting of its trial first seen on January 15th 2014 and most recently updated November 19th 2022. The study requires 40 participants to be recruited from two clinical sites.

Q: What medical conditions is Plerixafor most often employed to address?

Plerixafor can be applied to address a range of medical issues, including stem cell mobilization, bone marrow transplantation and febrile neutropenia.

Q: Is Plerixafor hazardous to human health?

Plerixafor has been assigned a rating of 2 on the safety scale, as this is only Phase 2 and there are no efficacy data available yet.

Q: Are other research projects exploring the potential of Plerixafor?

Currently, there are 175 active studies involving Plerixafor with 37 of those trials at Phase 3. While a number of these clinical tests for the drug have taken place in Saint Louis, <a href="https://www.withpower.com/clinical-trials/missouri">Missouri</a>, this research is being conducted globally in 4726 different sites.

Phase 2

Recruiting

Led By Irini Sereti, M.D.

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

HTLV-1 and HTLV-2 seronegative

Persons with documented history of ICL with genetic defects related to hematopoietic cells

Timeline

Screening 3 weeks

Treatment Varies

Follow Up throughout the study

Awards & highlights

Study Summary

This trial is testing a combination of drugs to see if they can help people with a rare syndrome called idiopathic CD4 lymphocytopenia. The syndrome is defined by low CD4 T cell counts, which can leave patients at risk for opportunistic infections. The drugs being tested are granulocyte colony stimulating factor (G-CSF) and plerixafor. The trial will involve healthy volunteers and patients with the syndrome.

Who is the study for?

This trial is for adults aged 18-65 with a rare condition called Idiopathic CD4 Lymphocytopenia (ICL), which involves very low levels of certain immune cells. Participants must have documented ICL, be HIV negative, and not currently have any serious illnesses or conditions that could interfere with the study. They should also agree to use effective birth control during the study.Check my eligibility

What is being tested?

The trial tests Plerixafor and Filgrastim's ability to mobilize stem cells in patients with ICL compared to healthy volunteers. These drugs may help move important progenitor cells into the bloodstream for collection and research on T cell development within mice models.See study design

What are the potential side effects?

Possible side effects include bone pain, headache, nausea, diarrhea, tiredness, and injection site reactions from Filgrastim; while Plerixafor can cause stomach upset, bloating or swelling at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I do not have HTLV-1 or HTLV-2.

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I have a genetic defect in my blood cells causing immune deficiency.

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I am healthy with a normal white blood cell count and hemoglobin level.

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I am between 18 and 65 years old.

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My weight is between 50 kg and 167 kg, and I am not over 175% of my ideal weight.

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I am willing to stay in the hospital for about a day.

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I can undergo procedures that require vein access.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ throughout the study

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~throughout the study

This trial's timeline: 3 weeks for screening, Varies for treatment, and throughout the study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

To assess peripheral CD4 T cell and CD34+ HPC numbers and functions in ICL subjects compared to controls following G CSF and plerixafor administration

Side effects data

From 2021 Phase 2 & 3 trial • 20 Patients • NCT02231879

37%

Bone pain

32%

Upper Respiratory Tract Infection

26%

Weight gain

16%

Blood alkaline phosphatase increased

16%

Upper respiratory infection

16%

Injection Site Reaction

16%

Hyperuricemia

16%

Hypocalcemia

16%

Headache

16%

Rash

11%

Tooth extraction

11%

Herpes simplex

11%

Urinary Tract Infection

11%

Abscess

11%

Pharyngitis

11%

Tinea corporis

11%

Fracture

11%

Migraine

11%

Acute bronchitis

11%

Elective surgery

11%

Acute sinusitis

11%

Alanine aminotransferase increased

11%

Creatinine increased

11%

Knee pain

11%

Arthralgia

11%

Papular rash

11%

Pruritic rash

Cellulitis

Iron Deficiency Anemia

Arthritis

Nausea

Skin Infection

Tinea capitis

Aspartate aminotransferase increased

Anemia

Tinnitus

Diarrhea

Infectious Diarrhea

Otitis media

Bone mineral content decreased

Hyperglycemia

Hypernatremia

Hyperkalemia

Joint pain

Low back pain

Ovarian cyst

100%

80%

60%

40%

20%

Study treatment Arm

Plerixafor

G-CSF

Trial Design

2Treatment groups

Experimental Treatment

Group I: PlerixaforExperimental Treatment1 Intervention

ICL and healthy volunteers will be given 0.24 mg/kg as a single dose (maximum dose: 40 mg) 11 hours prior to apheresis

Group II: FilgrastimExperimental Treatment1 Intervention

ICL and healthy volunteers will be given 10 microgram/kg daily for 5 days administered according to a vial-based algorithm to reduce wastage and increase the G-CSF dose given to lighter-weight donors to improve CD34+ yields

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Filgrastim

2000

Completed Phase 3

~3670

Plerixafor

2011

Completed Phase 3

~720

0 / 7Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,269 Previous Clinical Trials

5,481,428 Total Patients Enrolled

Irini Sereti, M.D.Principal InvestigatorNational Institute of Allergy and Infectious Diseases (NIAID)

8 Previous Clinical Trials

2,607 Total Patients Enrolled

Media Library

Filgrastim (Growth Factor) Clinical Trial Eligibility Overview. Trial Name: NCT02015013 — Phase 2

CD4 Positive T-Cell Lymphocytopenia Research Study Groups: Plerixafor, Filgrastim

CD4 Positive T-Cell Lymphocytopenia Clinical Trial 2023: Filgrastim Highlights & Side Effects. Trial Name: NCT02015013 — Phase 2

Filgrastim (Growth Factor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02015013 — Phase 2

Frequently Asked Questions

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

Are any openings left for those wishing to partake in this medical experiment?

"The information posted on clinicaltrials.gov confirms that this trial is currently seeking patient participation; the original posting was made on January 15th 2014, and it has had its last update logged as November 19th 2022."

Answered by AI

Are persons of senior age excluded from participating in this medical experiment?

"This medical trial requires that participants are betwixt 18 and 65 years old. However, there are 80 trials for minors and 110 for seniors who may not qualify to join this study."

Answered by AI

Who is eligible for inclusion in this research endeavor?

"This trial seeks out 40 individuals, aged 18 to 65, who are currently suffering from lymphopenia. To qualify for the study, all applicants must fulfill a variety of criteria: CD4 T cell count <300 cells/microL or <20% of total T lymphocytes on 2 occasions at least 6 weeks apart in the absence of any illness or medications accounting for CD4 lymphocytopenia; Hemoglobin greater than 9 g/dL; HTLV-1 and HTLV-2 seronegative status; Genetic analysis revealing inherited defects that could influence hematopoietic cell development, maturation, and home"

Answered by AI

How many individuals are eligible to join this research?

"Affirmative. Clinicaltrials.gov confirms that this medical research is actively seeking volunteers, with the posting of its trial first seen on January 15th 2014 and most recently updated November 19th 2022. The study requires 40 participants to be recruited from two clinical sites."

Answered by AI

What medical conditions is Plerixafor most often employed to address?

"Plerixafor can be applied to address a range of medical issues, including stem cell mobilization, bone marrow transplantation and febrile neutropenia."

Answered by AI

Is Plerixafor hazardous to human health?

"Plerixafor has been assigned a rating of 2 on the safety scale, as this is only Phase 2 and there are no efficacy data available yet."

Answered by AI

Are other research projects exploring the potential of Plerixafor?

"Currently, there are 175 active studies involving Plerixafor with 37 of those trials at Phase 3. While a number of these clinical tests for the drug have taken place in Saint Louis, Missouri, this research is being conducted globally in 4726 different sites."

Answered by AI

Recent research and studies

International Archives of Allergy and ImmunologyJournal

Idiopathic CD4+ Lymphocytopenia May Be Due to Decreased Bone Marrow Clonogenic Capability

Isgrò, Antonella, Maria Caterina Sirianni, Claudia Gramiccioni, Ivano Mezzaroma, Alessandra Fantauzzi, and Fernando Aiuti. 2005. “Idiopathic CD4+ Lymphocytopenia May Be Due to Decreased Bone Marrow Clonogenic Capability”. International Archives of Allergy and Immunology. S. Karger AG. doi:10.1159/000084258.

International Archives of Allergy and ImmunologyJournal

Lymphocyte Diversity in a 9-year-old Boy with Idiopathic CD4+ T Cell Lymphocytopenia

Frühwirth, Martin, K. Clodi, Andreas Heitger, and Nikolaus Neu. 2001. “Lymphocyte Diversity in a 9-year-old Boy with Idiopathic CD4+ T Cell Lymphocytopenia”. International Archives of Allergy and Immunology. S. Karger AG. doi:10.1159/000053800.

International ImmunologyJournal

Defective P56lck Activity in T Cells from an Adult Patient with Idiopathic CD4+ Lymphocytopenia

Hubert, Pascale, Florence Bergeron, Valérie Ferreira, Maxime Seligmann, Eric Oksenhendler, Patrice Debre, and Brigitte Autran. 2000. “Defective P56lck Activity in T Cells from an Adult Patient with Idiopathic CD4+ Lymphocytopenia”. International Immunology. Oxford University Press (OUP). doi:10.1093/intimm/12.4.449.

clinicaltrials.govStudy