Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Rare Diseases

Leukemia

Leukemia, Lymphoid

Influenza, Human

Leukemia, Lymphocytic, Chronic, B-Cell

Neoplasms by Histologic Type

Hematologic Diseases

Communicable Diseases

Respiratory Tract Infections

Orthomyxoviridae Infections

Virus Diseases

RNA Virus Infections

Respiratory Tract Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Leukemia, B-Cell

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Chronic Lymphocytic Leukemia

All Drugs and Chemicals

Anti-Infective Agents

Antineoplastic Agents

Vaccines

Interferons

Interferon-alpha

Peginterferon alfa-2a

Interferon alpha-2

Antiviral Agents

Immunologic Factors

TIV (Influenza Vaccine Trivalent Inactivated) alone

15 μg (0.5 ml) through needle into arm muscle on Days 1 and 28.

Influenza Vaccine Trivalent Inactivated (TIV)

180 μg (0.5 ml) before receiving TIV, through a needle under the skin.

Pegylated interferon (PEGrIFN-α, Pegasys)

3 million units (0.5 ml) before receiving TIV, through a needle under the skin.

Interferon (IFNα, Roferon-A)

Amar Safdar, MD

The goal of this clinical study is to learn if Pegasys (pegylated interferon) or Roferon (interferon) can make the Trivalent Inactivated Influenza vaccine (TIV) more effective in increasing the body's immune reaction against the flu virus in patients with Chronic Lymphocytic Leukemia (CLL).

The Study Drugs:

Pegylated interferon and interferon are designed to stop the growth of viruses. Pegylated interferon has a molecule that makes it last longer in the body. Standard interferon does not have this molecule that makes it last longer.

TIV is designed to prevent the flu.

Screening Test:

Before you can start treatment on this study, you will have a "screening test" to help the doctor decide if you are eligible to take part in this study. Blood (about 4 teaspoons) will be drawn for routine tests. If you have had a routine blood test in the last 4 weeks, this blood will not need to be drawn. Women who are able to have children must have a negative blood (about 1 teaspoon) blood test within 2 weeks of study entry.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the roll of dice) to 1 of 3 groups.

If you are assigned to Group 1, you will receive TIV alone. If you are assigned to Group 2, you will receive pegylated interferon with TIV. If you are assigned to Group 3, you will receive interferon with TIV.

You will have an equal chance of being assigned to any of the 3 groups. Your doctor, the study doctor, study staff, and you will know which group you are in.

Study Drug Administration:

You will receive TIV through a needle into a muscle in your arm (the arm you do not write with) on Days 1 and 28.

* If you are in Group 1, you will only receive TIV
* If you are in Group 2, you will receive pegylated interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.
* If you are in Group 3, you will receive interferon right before you receive TIV. It will be given through a needle under the skin. It will be given near the TIV injection site.

After you are given the injection(s), you will be watched for 15 minutes in the clinic before you are allowed to go home.

You will keep a diary for 1 week (7 days) after the injection(s). In it, you will record any symptoms you may be experiencing, and you will also record your body temperature.

Study Visits:

On Day 1, blood (about 4 teaspoons) will be drawn to check your immune system's response to the flu virus.

On Day 8, you will be asked to return to the clinic and your symptom/temperature diary will be reviewed. If you cannot come to the clinic, a member of the research staff will call you to review this information. This phone call will take 15-30 minutes.

On Day 28, blood (about 4 teaspoons) will be drawn to check your immune system response to the flu virus.

On Day 56, blood (about 4 teaspoons) will be drawn to check you immune system response to the flu virus. If you live out of town and cannot return to M. D. Anderson for this visit, you may have your blood drawn at a local clinic. You will then mail the blood to the study doctor in a pre-paid envelope.

On Month 6, you will be called and asked about any side effects you may have experienced. This phone call will take 15-30 minutes.

Length of Study:

You will be considered off study after the Month 6 phone call. You will be taken off-study early if intolerable side effects or an allergic reaction occurs.

This is an investigational study. TIV, pegylated interferon, and interferon are FDA approved and commercially available. At this time, the use of pegylated interferon and standard interferon with TIV is only being used for research.

Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.

Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia

A Randomized, Phase I/II Clinical Trial Evaluating the Safety, Reactogenicity, and Immunogenicity of Licensed Trivalent Influenza Vaccine Administered With Recombinant Interferon Alpha Among Patients With Chronic Lymphocytic Leukemia

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

Nervous System Diseases

Behaviors and Mental Disorders

Digestive System Diseases

Heart and Blood Diseases

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Substance Related Disorders

Eczema

Kidney Diseases

Diabetes Mellitus

Hypercholesterolemia

Alzheimer Disease

Depression

Depressive Disorder

Liver Diseases

Obesity

Heart Diseases

Arthritis

Liver Cirrhosis

Osteoporosis

Bulimia

Bulimia Nervosa

Acquired Immunodeficiency Syndrome

HIV Infections

Hypersensitivity

Intestinal Diseases

Dyspepsia

Gout

Bronchitis

Appendicitis

Cellulitis

Liver Diseases, Alcoholic

Infectious Mononucleosis

Renal Insufficiency, Chronic

Renal Insufficiency

Dementia

Brain Diseases

Central Nervous System Diseases

Tauopathies

Neurodegenerative Diseases

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Urologic Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Male Urogenital Diseases

Gastrointestinal Diseases

Bone Diseases

Bone Diseases, Metabolic

Metabolic Diseases

Intraabdominal Infections

Gastroenteritis

Cecal Diseases

Bronchial Diseases

Lung Diseases

Lung Diseases, Obstructive

Hyperphagia

Signs and Symptoms, Digestive

Skin Diseases

Skin Diseases, Infectious

Suppuration

Connective Tissue Diseases

Inflammation

Hyperlipidemias

Hyperlipoproteinemias

Dyslipidemias

Lipid Metabolism Disorders

Alcohol-Induced Disorders

Alcohol-Related Disorders

Substance-Related Disorders

Chemically-Induced Disorders

Familial Alzheimer Disease

Philippe B Wilson

Daniel JS Wolski

Imran Kapasi

Rishabh Prasad

This research programme seeks to combine the resources of NHS primary care, with the leading spectroscopic work in low-magnetic fields of the Wilson Group (Nottingham Trent University) to demonstrate the potential for benchtop Nuclear Magnetic Resonance (NMR) spectroscopy in human clinical pathology. This is an instrument assessment study for point of care viability which will also result in enhanced patient care (pending their consent) in blood screenings and metabolic health data.

The research project aims to gauge the efficacy of benchtop Nuclear Magnetic Resonance devices in a primary health care setting. The study design and methodology is as follows:

Typically, before a patient attends their routine standard of care blood test, they will speak with their local General Practitioner (GP) or a Registered Nurse (RN). At these visits, the medical professional will gauge the interest of the patient and test if they are eligible. If the patient is interested in becoming involved with research, and they are eligible for the study, they will be given a 'Study Information and Informed Consent Form' to read before their next visit. This allows for ample time to become fully informed on what the study entails, as well as to ask any questions they may have.

The 'Study Information and Informed Consent Form' document contains all information detailing: the purpose of the study, the significance of the research, and the patient's right to withdraw at any time (as in accordance with General Data Protection Regulations \[GDPR\] 2018), potential risks and benefits of taking part in the study and who to contact if the patient had any further questions to be asked.

At the patient's routine standard of care visit, they will present their signed and dated consent form to the medical professional taking the biological samples. If the patient loses their consent form before this visit, they will be given another to complete in full before any residual biological samples are taken. This will be counter-signed by the medical professional present at their visit. The patient will then be anonymised by being given a unique identifier in the form of a barcode. This barcode will be applied to the consent form, and the form will act as a linking document. The patient will only be referred by their unique identifier for the remainder of the study. This anonymisation of identifiable patient information (such as name, Date of Birth \[DoB\], etc.) extends to any data produced by analysing the patient's samples. The patient will keep a copy of the consent form for their own records, whilst the original document will be held by the research team to be stored on-site behind several layers of security. A copy of the consent form will also be uploaded onto the patients SystmOne profile. SystmOne is a clinical computer system used by medical professionals to log patient visits, review tests results and upload any new relevant data.

After sample collection, no further actions are required of the patient for the remainder of the study. The patient will be given a debriefing document thanking them for their contribution. Within this document there are contact details of the researchers involved and other contact telephone numbers to a variety of organisations and helplines specialising in emotional support, if the patient feels in any way affected by the study. The patient will also be offered the opportunity to be given a copy of their bio fluid spectral data should they be interested in this. This will be accompanied by explanatory notes.

The biological samples collected from the patient will go to two different locations: samples taken as part of the patient's routine standard of care will go to a local diagnostics lab where they will be tested on a variety of metrics. Residual biological samples will be processed and tested at the local Willows Health Near Patient Testing laboratory, before being frozen at -80oC.

The test results provided by the diagnostics lab will be uploaded to the patient's SystmOne account, where they will be scribed and used for the study, as outlined in the 'Study Information and Informed Consent Form' document. Results gathered from the Willows Health Near Patient Testing laboratory will also be uploaded to the patients SystmOne account and stored for later use within the study. The combination of these two sets of data will form the Near Patient Testing data set.

The residual biological samples frozen at Willows Health will then be transferred in batch format to Nottingham Trent University's (NTU's) benchtop Nuclear Magnetic Resonance device. They will then be thawed, prepared further and analysed using the benchtop Nuclear Magnetic Resonance device. The resultant spectra will be stored on the password protected device to form the benchtop Nuclear Magnetic Resonance data set. With both sets of data gathered (Near Patient Testing suite and benchtop Nuclear Magnetic Resonance spectra), a machine learning algorithm will cross-compare the data sets to 'teach' a program to 'read' the benchtop Nuclear Magnetic Resonance spectra and output data in the form of Near Patient Testing machines.

On average, \~42 patients attend the Willows Health Medical Centre for routine standard of care visits per week in which biological samples are collected for pathology lab testing. This equates to \~168 samples per month. With the sample collection window planned to take a year, this calculates to \~2016 potential participants being involved within the study. This is an estimated maximum, as not all patients who come for their annual review may not consent to the research study. Additionally, some religious events and holidays may limit the uptake of potential participants, for example: during Ramadan, although it is not strictly prohibited, blood tests may be avoided due to the weakening effect it may have. This, in conjunction with fasting, may dissuade potential participants from joining the study.

Given the substantial volumes of data required to 'train' software when utilising machine learning algorithms, the sample size needs to be large. This is imperative to produce accurate and reliable results from training and test sets for machine learning algorithms.

This research will result in several advantages for both clinical care and patients. For instance, efficient and rapid analysis of biological fluids will help to overcome the limitations associated with diagnosis of a variety of diseases such diabetes, chronic kidney disease, cancer and any other conditions that might go asymptomatic in the early stages. This work has the potential to pave the way for new clinical pathological techniques to support the early diagnosis of diseases.

Residual samples will be collected from patients visiting the Willows Health Medical Centre for their routine standard of care checkups.

Residual biological samples will be comprised of whole blood which will be processed into serum, analysed on local Near Patient Testing machines and frozen at -80'C. They will then be transported to Nottingham Trent University, thawed and analysed on the benchtop Nuclear Magnetic Resonance device.

Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)

Preclinical Drug Discovery Informed by Public Health: Initiating a Step-Change in the Development of New Human Models

An \>0.97 (or 97%) area under the receiver operating characteristic (AUROC) of benchtop Nuclear Magnetic Resonance versus current Point of Care (POC) testing sensitivity/specificity in conditional classification of samples.

Nottingham Trent University

Willows Health

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Congenital Abnormalities

Hematologic Neoplasms

Neoplasm, Residual

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Chromosome Aberrations

Monosomy

Chromosome Disorders

Lymphoma

Nerve Sheath Neoplasms

Neoplasms, Nerve Tissue

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Neoplastic Processes

Bone Marrow Diseases

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Aneuploidy

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Neurofibromatosis

Neurofibromatosis Type 1

Lymphosarcoma

Chronic Myeloproliferative Disorders

Myelodysplastic/myeloproliferative Disease

Antirheumatic Agents

Anticonvulsants

Nootropic Agents

Fludarabine

Fludarabine phosphate

Rituximab

Melphalan

Levetiracetam

Busulfan

Antineoplastic Agents, Immunological

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will be treated on the most medically appropriate regimen with a preference for Flu/TBI Arm followed by an infusion at Day 0 of Alpha/Beta T Cell-Depleted Hematopoietic Stem Cells.

Flu/Bu/Mel will the preference for patients with JMML or infants with leukemia.

Fludarabine 25mg/m2 IV on days -8 to -6 or days -4 to -2. 40mg/m2 IV on days -5 to -2.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reactogenicity, Immunogenicity of Trivalent Influenza Vaccine With Recombinant Interferon Alpha Among Chronic Lymphocytic Leukemia	NCT00962715	Chronic Lymphoc...	Influenza Vacci... Pegylated inter... Interferon (IFN...	18 Years -	M.D. Anderson Cancer Center
Benchtop NMR Spectroscopy for Assessment of Clinical Human Pathologies (BRANCH-P STUDY)	NCT05473325	Diabetes Chronic Kidney ... Cancer Bowel Disease Cardiovascular ... Mononucleosis Flu Heart Diseases HIV Infections AIDS and Infect... Bulimia Chest Infection... Arthritis Leukaemia Alcoholic Liver... Allergies Alzheimer Disea... Appendicitis Eczema Bronchitis Cellulitis Cirrhosis Depression Gout High Cholestero... Indigestion Obesity Osteoporosis		18 Years -	Willows Health
MT2021-08T Cell Receptor Alpha/Beta Depletion PBSC Transplantation for Heme Malignancies	NCT05735717	Hematologic Mal... Acute Leukemia Remission Acute Myeloid L... Acute Lymphobla... AML TP53 Intrachromosoma... Cytogenetic Abn... CNS Leukemia Minimal Residua... Myelodysplasia Juvenile Myelom... Somatic Mutatio... PTPN11 Gene Mut... N-RAS Gene Ampl... Neurofibromatos... NF1 Mutation CBL Gene Mutati... Monosomy 7 Chromosome Abno... Fetal Hemoglobi...	Fludarabine Busulfan Melphalan Rituximab Levetiracetam	- 60 Years	Masonic Cancer Center, University of Minnesota

Spots Global Cancer Trial Database for flu

Every month we try and update this database with for flu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for flu

Every month we try and update this database with for flu cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for flu cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.