Idiopathic CD4+ T-LymphocytopeniaPhase 1/2NCT00839436
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)
A Phase 1/2 study testing CYT107 in people with Idiopathic CD4+ T-Lymphocytopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic CD4+ T-Lymphocytopenia
- What is being tested?
- CYT107
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Sep 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
- 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
Show all 29Show fewer
- 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
- Concurrent breastfeeding
- Renal insufficiency (e.g., estimated glomerular filtration rate less than 60 mL/min/1.73 m(2))
- Any of the following screening laboratory abnormalities: platelets less than 100,000 cells/microL; lipase greater than 1.5 times the ULN; AST, ALT, or alkaline phosphatase greater than 2.5 times the ULN; total bilirubin greater than 1.5 times the ULN
- History of splenectomy or hematologic disease associated with hypersplenism, such as alpha- or beta-thalassemia, hereditary spherocytosis, Gaucher s disease, or autoimmune hemolytic anemia
- Cirrhosis of any origin, including alcoholic or non-alcoholic steatohepatitis, either suspected by history or histologically proven
- History of hepatitis B or C infection, i.e., positive hepatitis B surface antigen, positive anti-hepatitis B core antibody with a detectable hepatitis B DNA viral load, positive anti-hepatitis C antibody and/or detectable hepatitis C RNA viral load (subjects who became negative for hepatitis B DNA or hepatitis C RNA following anti-viral treatment will not qualify for study treatment)
- Need for anticoagulant medication (e.g., warfarin, heparin), other than aspirin, clopidogrel, or other antiplatelet agent as CYT107 may co-precipitate with heparin if taken together.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements (subjects must agree to refrain from substance abuse use during the entire course of the study)
- Past or current psychiatric illness that, in the opinion of the investigator, would interfere with protocol adherence or the ability and willingness to give written informed consent
- Current autoimmune conditions requiring systemic (oral, injection, or other parenteral) therapy, as well as psoriasis and optic neuritis regardless of treatment and/or a diagnosis of systemic lupus erythematous based on the screening rheumatologic work up.
- 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
- History of cardiovascular disease, arrhythmias, or clinically significant ECG abnormalities, including a corrected QT interval (QTc) greater than or equal to 470 milliseconds
- Family history consistent with an inherited cardiomyopathy or arrhythmia such as the following:
- Arrhythmogenic Right Ventricular Dysplasia (ARVD)
- Brugada syndrome (BrS)
- Congenital Long QT (LQT)
- Congenital Short QT intervals (SQT)
- Early Repolarization Syndrome
- Idiopathic Ventricular Fibrillation (IVF)
- Uncontrolled hypertension (i.e., resting systolic blood pressure greater than160 mmHg or resting diastolic blood pressure greater than 90 mmHg), despite pharmacologic antihypertensive treatment, confirmed with a second blood pressure measurement done later in the same day.
- Evidence of circulating neutralizing anti-IL-7 antibodies (prior to initial rhIL-7 administration)
- To be eligible for rhIL-7 administration, all Exclusion Criteria are prohibited. However, for the purpose of performing baseine pre-IL-7 procedures certain Exclusion Criteria designed to minimize specific complications from rhIL-7 (e.g., autoimmune or lymphoproliferative complications) but that do not increase the risk associated with these procedures are permitted, as baseline procedures will be done prior to IL-7 administration: #6, #11, through #13, #17, #18, #20, #22.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE) is a Phase I/IIa open-label, single arm clinical trial evaluating the safety profile of glycosylated recombinant human interleukin-7 (rhIL-7) as an immunostimulatory therapy in patients with idiopathic CD4 T cell lymphocytopenia (ICL) at risk of disease progression. Secondary analyses will assess the immunostimulatory effects of rhIL-7 on T cell number and function.
ICL was first characterized in the early 1990 s and is a primary immune disorder of CD4 T cell lymphocytopenia (less than 300 cells/microL or less than 20% of lymphocytes), which is not due to any known infectious process, exogenous medication, autoimmune cytopenia, or other underlying disorder associated with lymphocytopenia. ICL patients are at risk for a wide spectrum of opportunistic and other serious infections, autoimmune disorders, and other types of lymphocytopenia. At present, no validated treatment exists for ICL, and treatment is directed primarily toward infectious complications once they arise. A first-generation form of rhIL-7 was shown in pre-clinical and Phase I studies in oncology and human immunodeficiency virus (HIV)-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells. CYT107 is a second-generation rhIL-7 product made by Cytheris via a recombinant mammalian cell culture system.
DESIGN - Open-label, single-arm, Phase I/IIa interventional clinical trial. Participants will be evaluated at baseline (prior to study treatment) and according to the protocol follow-up schedule, receiving a total of 2 cycles of rhIL-7 (CYT107) during the induction phase and up to 8 cycles during the maintenance phase. Safety assessments of rhIL-7 will be the primary focus at each study visit, with secondary analyses of immune parameters, including changes from baseline in T cell number and function at Weeks 24 and 48.
DURATION - Enrollment is expected to take 3 to 4 years. Each volunteer will be followed for at least 48 weeks. Thus, total duration of the study will be approximately 5 years.
SAMPLE SIZE - Approximately 35-40 patients will be screened over a 3-year period to achieve the desired sample of 18 ICL patients, allowing for a primary safety assessment of CYT107 in this Phase I/IIa clinical trial, as well as exploring the immunomodulatory effects of rhIL-7.
POPULATION - Men and women, aged greater than or equal to 18 years, with a confirmed diagnosis of ICL (CD4 less than 300 cells/micromL or less than 20% of lymphocytes) deemed at risk for complications due to concurrent CD8 T cell lymphocytopenia and/or history of opportunistic or otherwise serious infection, without autoimmunity or hematologic or lymphoid malignancy.
REGIMEN - During the induction phase, subjects will receive 2 cycles of subcutaneous rhIL-7 dosed once weekly for 3 weeks in a dose escalation fashion: 3 microg/kg (first 3 subjects-completed), 10 microg/kg (next 5 subjects-completed) and 20 microg/kg (last 5 subjects), with an additional 5 subjects at the highest achieved dose level. Cycles of rhIL-7 will be administered starting at Week 1 and Week 24.
For subjects who tolerate the induction phase and elect to participate in the
maintenance phase, additional cycles of rhIL-7 may be offered at 3-6 month
intervals. These participants will receive rhIL-7 at the highest dose for which at
least 8 weeks of safety data for 5 subjects has been reviewed provided no more
than 1 DLT is reported.
- Conditions
- Idiopathic CD4+ T-Lymphocytopenia
- Being tested
- CYT107
- Keywords
- Idiopathic CD4+ T-Lymphocytopenia, Interleukin-7, Clinical Trial, T-Lymphocytes, Idiopathic CD4 Lymphocytopenia (ICL), ICL
- Medical subject headings
- T-Lymphocytopenia, Idiopathic CD4-Positive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CYT107Drug
| Study group | Role | What they receive |
|---|---|---|
| 3 microgram/kg CYT107 | Experimental | 3 microgram/kg CYT107 Receives: Drug: CYT107 |
| 10 microgram/kg CYT107 | Experimental | 10 microgram/kg CYT107 Receives: Drug: CYT107 |
| 20 microgram/kg CYT107 | Experimental | 20 microgram/kg CYT107 Receives: Drug: CYT107 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events and Toxicities Associated With CYT107.
Measured: 48 weeks per patient with a 3-4 year enrollment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionMay 2014
- Study completionSep 2014
Why it stopped: Bankruptcy of Drug manufacturer: Drug not available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Idiopathic CD4+ T-LymphocytopeniaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Virginia M Sheikh, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00839436
- Sponsor's protocol ID
- 090069
- Other IDs
- 09-I-0069
- Status last verified
- Oct 2015
- First submitted
- 6 Feb 2009
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Smith DK, Neal JJ, Holmberg SD. Unexplained opportunistic infections and CD4+ T-lymphocytopenia without HIV infection. An investigation of cases in the United States. The Centers for Disease Control Idiopathic CD4+ T-lymphocytopenia Task Force. N Engl J Med. 1993 Feb 11;328(6):373-9. doi: 10.1056/NEJM199302113280601.
PubMed 8093633Walker UA, Warnatz K. Idiopathic CD4 lymphocytopenia. Curr Opin Rheumatol. 2006 Jul;18(4):389-95. doi: 10.1097/01.bor.0000231908.57913.2f.
PubMed 16763460Bofill M, Janossy G, Lee CA, MacDonald-Burns D, Phillips AN, Sabin C, Timms A, Johnson MA, Kernoff PB. Laboratory control values for CD4 and CD8 T lymphocytes. Implications for HIV-1 diagnosis. Clin Exp Immunol. 1992 May;88(2):243-52. doi: 10.1111/j.1365-2249.1992.tb03068.x.
PubMed 1349272Sheikh V, Porter BO, DerSimonian R, Kovacs SB, Thompson WL, Perez-Diez A, Freeman AF, Roby G, Mican J, Pau A, Rupert A, Adelsberger J, Higgins J, Bourgeois JS Jr, Jensen SM, Morcock DR, Burbelo PD, Osnos L, Maric I, Natarajan V, Croughs T, Yao MD, Estes JD, Sereti I. Administration of interleukin-7 increases CD4 T cells in idiopathic CD4 lymphocytopenia. Blood. 2016 Feb 25;127(8):977-88. doi: 10.1182/blood-2015-05-645077. Epub 2015 Dec 16.
PubMed 26675348
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE)
- ClinicalTrials.gov ID
- NCT00839436
- Acronym / sponsor ID
- 090069
- Conditions
- Idiopathic CD4+ T-Lymphocytopenia
- Keywords
- Idiopathic CD4+ T-Lymphocytopenia, Interleukin-7, Clinical Trial, T-Lymphocytes, Idiopathic CD4 Lymphocytopenia (ICL), ICL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Bankruptcy of Drug manufacturer: Drug not available
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 9 Feb 2009 (estimated)
- Results
- Posted 15 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Interleukin-7 (CYT107) Treatment of Idiopathic CD4 Lymphocytopenia: Expansion of CD4 T Cells (ICICLE) is a Phase I/IIa open-label, single arm clinical trial evaluating the safety profile of glycosylated recombinant human interleukin-7 (rhIL-7) as an immunostimulatory therapy in patients with idiopathic CD4 T cell lymphocytopenia (ICL) at risk of disease progression. Secondary analyses will assess the immunostimulatory effects of rhIL-7 on T cell number and function.
ICL was first characterized in the early 1990 s and is a primary immune disorder of CD4 T cell lymphocytopenia (less than 300 cells/microL or less than 20% of lymphocytes), which is not due to any known infectious process, exogenous medication, autoimmune cytopenia, or other underlying disorder associated with lymphocytopenia. ICL patients are at risk for a wide spectrum of opportunistic and other serious infections, autoimmune disorders, and other types of lymphocytopenia. At present, no validated treatment exists for ICL, and treatment is directed primarily toward infectious complications once they arise. A first-generation form of rhIL-7 was shown in pre-clinical and Phase I studies in oncology and human immunodeficiency virus (HIV)-infected patients to be well tolerated in repeated dose trials, with long-lasting increases in both CD4 and CD8 T cells. CYT107 is a second-generation rhIL-7 product made by Cytheris via a recombinant mammalian cell culture system.
DESIGN - Open-label, single-arm, Phase I/IIa interventional clinical trial. Participants will be evaluated at baseline (prior to study treatment) and according to the protocol follow-up schedule, receiving a total of 2 cycles of rhIL-7 (CYT107) during the induction phase and up to 8 cycles during the maintenance phase. Safety assessments of rhIL-7 will be the primary focus at each study visit, with secondary analyses of immune parameters, including changes from baseline in T cell number and function at Weeks 24 and 48.
DURATION - Enrollment is expected to take 3 to 4 years. Each volunteer will be followed for at least 48 weeks. Thus, total duration of the study will be approximately 5 years.
SAMPLE SIZE - Approximately 35-40 patients will be screened over a 3-year period to achieve the desired sample of 18 ICL patients, allowing for a primary safety assessment of CYT107 in this Phase I/IIa clinical trial, as well as exploring the immunomodulatory effects of rhIL-7.
POPULATION - Men and women, aged greater than or equal to 18 years, with a confirmed diagnosis of ICL (CD4 less than 300 cells/micromL or less than 20% of lymphocytes) deemed at risk for complications due to concurrent CD8 T cell lymphocytopenia and/or history of opportunistic or otherwise serious infection, without autoimmunity or hematologic or lymphoid malignancy.
REGIMEN - During the induction phase, subjects will receive 2 cycles of subcutaneous rhIL-7 dosed once weekly for 3 weeks in a dose escalation fashion: 3 microg/kg (first 3 subjects-completed), 10 microg/kg (next 5 subjects-completed) and 20 microg/kg (last 5 subjects), with an additional 5 subjects at the highest achieved dose level. Cycles of rhIL-7 will be administered starting at Week 1 and Week 24.
For subjects who tolerate the induction phase and elect to participate in the
maintenance phase, additional cycles of rhIL-7 may be offered at 3-6 month
intervals. These participants will receive rhIL-7 at the highest dose for which at
least 8 weeks of safety data for 5 subjects has been reviewed provided no more
than 1 DLT is reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 3 microgram/kg CYT107 | Experimental | Drug: CYT1073 microgram/kg CYT107 |
| 10 microgram/kg CYT107 | Experimental | Drug: CYT10710 microgram/kg CYT107 |
| 20 microgram/kg CYT107 | Experimental | Drug: CYT10720 microgram/kg CYT107 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (29 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CYT107 | Drug | 10 microgram/kg CYT107, 20 microgram/kg CYT107, 3 microgram/kg CYT107 |
Primary outcome
Adverse Events and Toxicities Associated With CYT107.
Time frame: 48 weeks per patient with a 3-4 year enrollment period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 8093633Smith DK, Neal JJ, Holmberg SD. Unexplained opportunistic infections and CD4+ T-lymphocytopenia without HIV infection. An investigation of cases in the United States. The Centers for Disease Control Idiopathic CD4+ T-lymphocytopenia Task Force. N Engl J Med. 1993 Feb 11;328(6):373-9. doi: 10.1056/NEJM199302113280601.
- Background: PubMed 16763460Walker UA, Warnatz K. Idiopathic CD4 lymphocytopenia. Curr Opin Rheumatol. 2006 Jul;18(4):389-95. doi: 10.1097/01.bor.0000231908.57913.2f.
- Background: PubMed 1349272Bofill M, Janossy G, Lee CA, MacDonald-Burns D, Phillips AN, Sabin C, Timms A, Johnson MA, Kernoff PB. Laboratory control values for CD4 and CD8 T lymphocytes. Implications for HIV-1 diagnosis. Clin Exp Immunol. 1992 May;88(2):243-52. doi: 10.1111/j.1365-2249.1992.tb03068.x.
- Derived from this study: PubMed 26675348Sheikh V, Porter BO, DerSimonian R, Kovacs SB, Thompson WL, Perez-Diez A, Freeman AF, Roby G, Mican J, Pau A, Rupert A, Adelsberger J, Higgins J, Bourgeois JS Jr, Jensen SM, Morcock DR, Burbelo PD, Osnos L, Maric I, Natarajan V, Croughs T, Yao MD, Estes JD, Sereti I. Administration of interleukin-7 increases CD4 T cells in idiopathic CD4 lymphocytopenia. Blood. 2016 Feb 25;127(8):977-88. doi: 10.1182/blood-2015-05-645077. Epub 2015 Dec 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginia M Sheikh, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CYT107 in people with Idiopathic CD4+ T-Lymphocytopenia, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events and Toxicities Associated With CYT107. (time frame: 48 weeks per patient with a 3-4 year enrollment period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00839436, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2015.