Infections

All Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Blood and Lymph Conditions

Immune System Diseases

COVID-19

Communicable Diseases

Coronavirus Infections

Lymphopenia

Pneumonia

Pneumonia, Viral

Respiratory Tract Infections

Virus Diseases

Coronaviridae Infections

Nidovirales Infections

RNA Virus Infections

Lung Diseases

Respiratory Tract Diseases

Leukopenia

Cytopenia

Hematologic Diseases

Leukocyte Disorders

Syndrome

Immunologic Deficiency Syndromes

Intramuscular (IM) administration of CYT107 twice a week for 3 weeks

Intramuscular (IM) placebo (normal saline) at the same frequency

IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay

CYT107

Same number, volume and frequency of IM administration of saline

Placebo

Steve Pastores, MD

Marcel van den Brink, MD, PhD

Comparison of the effects of CYT107 vs Placebo administered IM at 10μg/kg twice a week for three weeks on immune reconstitution of lymphopenic COVID-19 patients

Approximately forty-eight (48) participants will be randomized 1:1 to receive

(a) Intramuscular (IM) administration of CYT107 at 10 μg/kg followed, after 72hrs of observation, by 10 μg/kg twice a week for 3 weeks (maximum 7 administrations adjusted to patient's length of stay in the hospital) or (b) Intramuscular (IM) placebo (normal saline) at the same frequency.

The aim of the study is to test the ability of CYT107 to produce an immune reconstitution of these patients and observe possible association with a clinical improvement.

This cohort is dedicated to oncology patients

randomized controlled of treatment vs placebo

Unblinded Pharmacist will prepare blinded syringes of colorless drug or placebo

InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )

A Multicenter, Randomized, Double-blinded Placebo-controlled Study of Recombinant Interleukin-7 (CYT107) for Immune Restoration of Hospitalized Lymphopenic Patients With Coronavirus COVID-19 Infection. US Oncology Cohort

Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0) to assess safety

A statistically significant increase of the absolute lymphocyte count (ALC) from randomization to day 30 or HospitalDischarge

to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by 11 steps WHO clinical improvement score

The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first)

Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45

Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)

Number of days in ICU during index hospitalization

Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days)

Number of readmissions to the hospital through Day 45

Absolute numbers of CD4+ and CD8+ T-cell counts at time points indicated on the Schedule of Activities (SoA) through Day 30 or HD

Track and evaluate other known biomarkers of inflammation, Ferritin, from baseline to day 30

Track and evaluate other known biomarkers of inflammation, CRP from baseline to day 30

Track and evaluate other known biomarkers of inflammation, D-dimer from baseline to day 30

Evaluate improvement of the NEWS2 score value. Score form 0 to 4: NO Risk Score of 7 or more: High risk

Memorial Sloan Kettering Cancer Center

Amarex Clinical Research

M.D. Anderson Cancer Center

Cancer Research Institute, New York City

Revimmune

Neoplasms

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m\^2 temozolomide per day for 15 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.

Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m\^2 temozolomide per day for 5 days starting the first day of radiotherapy. This treatment will be followed by standard monthly 5 day cycles at 150 mg/m\^2 for upto 1 year.

Radiation Therapy

Oral Temozolomide (150mg/m\^2 or 75 mg/m\^2)

Temozolomide Oral Product

John Flickinger, MD

This is a prospective, randomized, open-label, exploratory trial of temozolomide-based chemo-radiotherapy which compares two widely used established radiation schedules with either 40 Gy in 15 fractions or 25 Gy in 5 fractions with concurrent temozolomide for both schedules in patients with glioblastoma.

All patients in the study will receive usual care with short-course radiotherapy (RT) and TMZ-chemo pills.

There are three phases of treatment in this study: the Chemo-radiation Phase, the Adjuvant Phase, and the Follow-Up Phase.

Twenty-eight or fewer days prior to starting the Chemo-radiation Phase, patients will have a baseline Magnetic Resonance Imaging (MRI) scan.

Chemo-radiation Phase: In this, patient will be assigned to either a one week or a three week treatment group with radiation treatments given approximately 5 days a week as directed by the study doctor. During this time they will also take TMZ-chemo orally (by mouth) once a day on every evening including weekends starting the evening of the day that you start radiotherapy. Once radiation is completed, you will stop taking TMZ-chemo for approximately 4 weeks before going to the next phase.

Radiation therapy: Patients will be randomized between standard radiation treatment at UPMC Radiation Oncology facilities included in this protocol with either 40 Gy in 15 fractions or 25 Gy in 5 fractions, using 6 to 23 MV x-rays along with concurrent temozolomide chemotherapy for both treatment schedules.

* Clinical treatment volumes (CTV) will include all contrast enhancing tumor plus 1.7cm expansion into brain tissue (not crossing the tentorium) and all T2 FLAIR hyperintensity plus 7mm expansion into brain tissue (not crossing the tentorium). A planning target volume (PTV) expansion of 3mm will be then added to the CTV. No additional exclusion of brainstem or optic nerves is required as both treatment schedules are within tolerance.
* Treatment may be delivered with either 3D-conformal or intensity modulated radiotherapy (IMRT) techniques.

Adjuvant Phase: In the Adjuvant Phase, you will receive standard monthly 5 day cycles of TMZ-chemo at 150 mg/m\^2 per day for up to 1 year.

Chemotherapy: Patient will receive concurrent temozolomide throughout radiation therapy, followed by standard monthly 5 day cycles for up to 1 year. Patients randomized to 25 Gy in 5 fractions will receive 150 mg/m\^2 of temozolomide per day for 5 days starting first day of radiotherapy. Patients randomized to 40 Gy in 15 fractions will receive 75 mg/m2 of temozolomide per day for 19 days starting first day of radiotherapy. Patients will be appropriately pre-medicated with anti-nausea medication, prior to taking temozolomide. All patients will also receive prophylactic treatment for pneumocystis pneumonia with Bactrim or other alternative antibiotics if allergic.

Follow-up Interval: Procedures performed to evaluate the safety and effectiveness of the study procedures are called "monitoring" or "follow-up" procedures. Subject participants will not be scheduled for any additional follow-up visits for this study than they would normally have if they were not in this study. Radiation Oncologists and Neuro-Oncologists usually see their patients one month after the first chemo-radiotherapy cycle before starting the next cycle of chemotherapy. After that Neuro-Oncologists and Radiation Oncologists will see the patients every 1-3 months.

Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma

Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma: Comparison of Two Established Schedules

The length of time from the start of treatment that patients remain alive.

Differences in absolute lymphocyte count (total lymphocyte count \<800 - 500/mm\^3 \<0.8 - 0.5 x 10\^9 /L) / total # patients, during treatment.

The length of time during and after the treatment that a patient lives without worsening disease per Response Assessment in Neuro-Oncology (RANO) criteria. Disease progression per RANO: (any of the following): ≥25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease) or best response, on stable or increasing doses of corticosteroids\*; significant increase in T2/FLAIR nonenhancing lesion on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy\* not caused by comorbid events; any new lesion; clear clinical deterioration not attributable to other causes apart from the tumor (eg, seizures, medication adverse effects) or changes in corticosteroid dose; failure to return for evaluation as a result of death or deteriorating condition; or clear progression of nonmeasurable disease.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune
Short Course Chemo-Radiation Therapy for Patients With Newly Diagnosed Glioblastoma	NCT04019262	Glioblastoma	Radiation Thera... Temozolomide Or...	18 Years -	University of Pittsburgh
InterLeukin-7 to Improve Clinical Outcomes in Lymphopenic Patients With COVID-19 Infection ( ILIAD-7-US-O )	NCT04426201	COVID-19 Lymphocytopenia	CYT107 Placebo	25 Years - 80 Years	Revimmune

Spots Global Cancer Trial Database for lymphocytopenia