Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICI… (NCT00839436) | Clinical Trial Compass
TerminatedPhase 1/2
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)
Stopped: Bankruptcy of Drug manufacturer: Drug not available
United States21 participantsStarted 2009-02
Plain-language summary
Background:
* Idiopathic CD4 lymphocytopenia (ICL) is a condition in which patients have low levels of T cells, a type of white blood cell that helps fight infection. Animal studies have shown that an experimental drug Interleukin 7 (IL-7), which is named CYT107, can increase the number and function of T cells. CYT107, however, has not been used in people with ICL.
Objectives:
* To determine the safety of CYT107 in people with ICL.
* To determine whether CYT107 will increase the number and function of T cells in people with ICL.
Eligibility:
* Patients 18 years of age and older diagnosed with ICL and who are at risk of becoming sick because of this condition are eligible for this study. In addition, patients must not be pregnant, or have other illnesses that would cause low CD4 T cell counts, such as human immunodeficiency virus (HIV) or human T-lymphotrophic virus (HTLV) infection.
Design:
* The initial screening visit will include the following examinations and tests:
* A complete physical exam and medical history
* Blood analysis, including CD4 T cell count; complete blood count and additional blood tests to determine clotting ability and blood composition; thyroid, liver, kidney, and pancreatic function tests; HIV and HTLV tests; and tests for anti-IL-7 antibodies that block normal IL-7 activity
* Routine urine test
* Urine or blood pregnancy test for women
* Chest X-ray
* Electrocardiogram
* Spleen ultrasound.
* The baseline visit will include blood tests to determine levels of each of the major types of antibodies, a test of genetic background, and more detailed CD4 and protein analysis. In addition, leukapheresis (a procedure to collect large numbers of immune cells without red blood cells) will be done. Participants will also have the option of having colon and lymph node biopsies.
* The schedule will be as follows:
* Weeks 1, 2, and 3 (Cycle 1): Three weekly IL-7 dosing visits.
* Weeks 5, 8, and 12: Follow-up visits.
* Weeks 24, 25, and 26 (Cycle 2): Three more weekly IL-7 dosing visits.
* Weeks 28, 31, and 35: Follow-up visits.
* Week 48: End of study visit.
* Tests conducted before getting IL-7 will be repeated during the IL-7 cycles and follow-up visits to compare with earlier values. Optional colon and lymph node biopsies done at baseline will be repeated 1 6 weeks prior to Cycle 2 and 1 6 weeks prior to Week 48.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age greater than or equal to 18 years
✓. CD4 T cell count less than 300 cells/microL or less than 20% of total T lymphocytes on 2 occasions at least 6 weeks apart (and at the time of screening) in the absence of any illness accounting for CD4 lymphocytopenia
✓. ICL diagnosis that indicates a risk for disease progression, defined as one or both of the following:
✓. HIV-1 and HIV-2 seronegativity and below detection of HIV-1 viral load
✓. HTLV-1 and HTLV-2 seronegativity
✓. Adequate venous access, as determined by the study team, although participants unable to undergo leukapheresis will not be excluded
✓. Normal thyroid-stimulating hormone (TSH)
✓. Negative serum or urine pregnancy test at time of study enrollment for women of childbearing potential
Exclusion criteria
✕. History of prior cytotoxic, chemotherapeutic, immunosuppressant (e.g., systemic corticosteroids), immunomodulatory (e.g., IL-2, IL-7, interferon-gama), or growth factor therapy within the last 6 months; chemotherapy or immunomodulatory therapy given to treat an underlying disease or condition may be permitted at the protocol team's discretion, provided diagnosis of ICL was established prior to starting this treatment. The treatment has been stable for over 6 months and is being administered at stable doses as maintenance therapy.
What they're measuring
1
Adverse Events and Toxicities Associated With CYT107.
Timeframe: 48 weeks per patient with a 3-4 year enrollment period
Trial details
NCT IDNCT00839436
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
✕. History of prior participation in another investigational intervention study within the last 6 months. Co-enrollment in other NIAID stem cell mobilization protocols will be permitted at the protocol team s discretion, but CYT107 may be dosed no sooner than 6 months after last dose of that protocol s medications have been given.
✕. Active uncontrolled opportunistic infection at the time of enrollment
✕. Current or recent history (less than 28 days prior to screening) of a viral, bacterial, parasitic or fungal infection requiring hospitalization and/or systemic treatment, other than long-term maintenance pharmacotherapy
✕. Serious illness requiring systemic treatment and/or hospitalization within 56 days (8 weeks) of screening, unless the subject is clinically stable, in the opinion of the Principal Investigator, and has completed therapy or has been on appropriate therapy for greater than 28 days (4 weeks) prior to screening
✕. Current or history of hematologic or lymphoid (lymphoma) malignancy
✕. Established or planned pregnancies or refusal to use effective birth control (e.g., barrier methods, oral contraceptives, intrauterine devices) for the duration of study involvement, regardless of gender