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New treatment option for Idiopathic CD4-Positive
Official title Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
ClinicalTrials.gov ID: NCT02015013
What this study is testing
What is Filgrastim?
Filgrastim is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for idiopathic cd4-positive.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Idiopathic CD4 lymphocytopenia (ICL) is a rare syndrome defined by consistently low CD4 T cell counts (\<300/mm3) without evidence of HIV infection or other known immunodeficiency. Patients with ICL are at risk for opportunistic infections typically associated with HIV/AIDS such as disseminated cryptococcal infection and severe human papillomavirus-related dysplasia.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- ICL patients:
- Documented history of idiopathic CD4 lymphocytopenia as defined by CD4 T cell count \<300 cells/microL or \<20% of total T lymphocytes on 2 occasions...
- Hemoglobin greater than or equal to 9 g/dL
- Human T-lymphotropic virus Type 1 (HTLV-1) and HTLV-2 seronegative
- Persons with documented history of ICL in whom genetic analysis revealed inherited defects that are either known or suspected to be involved in...
You likely can't join if
- Active uncontrolled infection at the time of enrollment
- Current autoimmune conditions requiring systemic (oral, injection, or other parenteral) therapy
- History of vasculitis
- Current or history of hematologic or lymphoid malignancy (leukemia)
- History of splenomegaly or current splenomegaly on exam or ultrasound (for ICL patients)
- History of hypersensitivity to plerixafor and/or G-CSF
See the full eligibility criteria
- ICL patients:
- Documented history of idiopathic CD4 lymphocytopenia as defined by 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...
- Hemoglobin greater than or equal to 9 g/dL
- Human T-lymphotropic virus Type 1 (HTLV-1) and HTLV-2 seronegative
- Persons with documented history of ICL in whom genetic analysis revealed inherited defects that are either known or suspected to be involved in development, maturation, or homeostasis of hematopoietic cells. Healthy...
- Age 18-65 years
- Weight at least 50 kg but less than 167 kg and \<175% ideal body weight (due to lack of data regarding appropriate dosing of plerixafor)
- Ability to give informed consent
- Capacity and willingness to adhere to study procedures, including scheduled follow-up visits
- Willingness to have blood samples stored for future research
- Willingness to undergo HLA testing
- Willingness to be hospitalized for approximately 24 hours
- Established primary care provider
- HIV-1 and HIV-2 seronegativity and plasma HIV-1 RNA polymerase chain reaction (PCR) below the limit of detection
- Adequate venous access to allow leukapheresis without use of a central line or a large volume blood draw
- Participant agrees to be heterosexually inactive or consistently use effective birth control (e.g., barrier methods, oral contraceptives, intrauterine devices, vasesctomy) for the duration of study participation and for...
- For women of childbearing potential:
- Negative serum or urine pregnancy test
- Active uncontrolled infection at the time of enrollment
- Current autoimmune conditions requiring systemic (oral, injection, or other parenteral) therapy
- History of vasculitis
- Current or history of hematologic or lymphoid malignancy (leukemia)
- History of splenomegaly or current splenomegaly on exam or ultrasound (for ICL patients)
- History of hypersensitivity to plerixafor and/or G-CSF
- Systemic immune-modulatory agent within the past 6 months
- Thrombocytopenia (platelets \<100,000 cells/microL)
- Hepatitis B and C seropositivity (HBsAg positive and anti-HCV positive) Need for anticoagulant medication (e.g., warfarin, heparin), other than aspirin, clopidogrel, or other antiplatelet agent
- Creatinine clearance \<50 mL/min including end-stage renal disease requiring hemodialysis
- Symptomatic coronary artery disease
- Uncontrolled hypertension (i.e., resting systolic blood pressure \>160 mmHg or resting diastolic blood pressure \>90 mmHg) despite pharmacologic antihypertensive treatment confirmed with a second blood pressure...
- Cardiac, pulmonary, thyroid, renal, hepatic, neurological (central or peripheral) disease or disorder of hemostasis requiring therapy and considered to be significant by the protocol team
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements
- Currently receiving lithium due to contraindication of co-administration of G-CSF with lithium
- Past or current psychiatric illness that, in the opinion of the investigator, would interfere with protocol adherence or the ability to give written informed consent
- Any illness or condition that, in the opinion of the investigator, may substantially increase the risk associated with participation in the study or compromise the scientific objectives
- Participation in a clinical protocol which includes an intervention that, in the opinion of the investigator, may affect the results of the current study
- Previous history of anaphylactic reaction to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Female of child-bearing potential who is breast-feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.