Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients (NCT03821038) | Clinical Trial Compass
TerminatedPhase 2
Recombinant Interleukin-7 (CYT107) to Restore Absolute Lymphocyte Counts in Sepsis Patients
Stopped: PK issue detected after bolus IV route administration
United States, France21 participantsStarted 2019-06-01
Plain-language summary
This phase II randomized study will assess the effect of receiving IV recombinant human IL-7 (CYT107) versus placebo in lymphopenic sepsis patients
The aim is to confirm the immune cell reconstitution observed in other studies and other patient populations among which the IRIS-7 A\&B study which was conducted in the same patient population.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion criteria
✓. A written, signed informed consent, by the patient or the patient's legally authorized representative
✓. Participants with an absolute lymphocyte count (ALC) ≤ 900 cells/mm3, at two time points at least twelve hours apart, following diagnosis of vasopressor dependent sepsis and,
✓. the second time point should not be performed earlier than 48 hours after sepsis diagnosis,
✓. study drug treatment initiation is required no later than 120 hours (up to 5 days) after the last qualifying ALC ≤ 900 cells/mm3 measure, and
✓. the average value of the two qualifying ALC counts will serve as a baseline to express the percent increase at day 29, or at hospital discharge.
✓. Patients in the ICU with onset of vasopressor dependent sepsis defined as hypotension requiring treatment with any vasopressor(s) for at least 6 hours to maintain a systolic pressure ≥ 90 mmHg or a mean arterial pressure ≥65 mmHg AND at least 1 of the 2 organ dysfunction criteria below:
✓. Acute respiratory failure defined as the need for invasive mechanical ventilation for at least 24 hours to support pulmonary function
✓. Acute kidney injury defined as creatinine \> 2.0 mg/dL (based on new abnormal result following onset of sepsis) OR urine output \< 0.5 mL/kg/hr for \> 4 hours despite adequate fluid resuscitation. In the presence of pre-existing impairment of renal function (defined as a serum creatinine concentration \>2 times the upper limit of the normal reference range prior to the onset of sepsis), the patient must meet the other organ dysfunction criteria.
. Cancer with current chemotherapy or radiotherapy (receipt of chemotherapy or radiotherapy for cancer within the last 6 weeks). All patients with current, or history of, hematologic malignancy (including, but not limited to, ALL, AML, CLL, CML, etc.) or lymphoma will be excluded, regardless of receipt of recent chemotherapy
✕. Patients with minimal chance of survival and life expectancy less than 3-5 days as defined by an APACHE II score of ≥ 35 at time of consideration for study eligibility
✕. Patients with history or current evidence of autoimmune disease including for example: myasthenia gravis, Guillain Barre syndrome, systemic lupus erythematosus, multiple sclerosis, scleroderma, ulcerative colitis, Crohn's disease, autoimmune hepatitis, Wegener's etc.
✕. Patients who have received a solid organ transplant or bone marrow transplant.
✕. Patients with active or a history of acute or chronic lymphocytic leukemia
✕. AIDS-defining illness (category C) diagnosed within the last 12 months prior to study entry
✕. Known history of chronic HBV infection and not on treatment with HBV nucleoside analogues prior to the current hospitalization or HBV DNA \> 100 IU/mL
✕. Known history of infection with HCV and currently undergoing treatment for HCV infections or has detectable HCV RNA