Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
First received: February 6, 2009
Last updated: November 27, 2013
Last verified: June 2013
- 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.
- 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.
- 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.
- 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
- 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- Adverse events and toxicities associated with CYT107. [ Time Frame: 48 weeks per patient with a 3-4 year enrollment period ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Change: CD4/CD8 T cell cts after CYT107; in immunophenotype (naive, memory, regulatory T cell subsets) & antigen-specific T cell function after CYT107; in T cell activation/proliferation status & TCR repertoire after CYT107; immunogeni... [ Time Frame: 48 weeks per patient with a 3-4 year enrollment period ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
Intervention Details:Show Detailed Description
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839436
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike|
|Bethesda, Maryland, United States, 20892|
Sponsors and Collaborators
|Principal Investigator:||Virginia M Sheikh, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|