Eye Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Ear, Nose, and Throat Diseases

Gland and Hormone Related Diseases

Behaviors and Mental Disorders

Rare Diseases

Cataract

Coronary Artery Disease

Heart Failure

Syndrome

Lung Diseases

Liver Diseases

Fatigue

Lymphoma

Leukemia

Heart Diseases

Hemorrhage

Communicable Diseases

Renal Insufficiency

Arrhythmias, Cardiac

Peripheral Nervous System Diseases

Hypersensitivity

Ischemia

Hypotension

Seizures

Myocardial Ischemia

Lung Diseases, Interstitial

Vertigo

Dizziness

Leukemia, T-Cell

Sleepiness

Thromboembolism

Hypothyroidism

Hypotension, Orthostatic

Confusion

Leukemia-Lymphoma, Adult T-Cell

Tumor Lysis Syndrome

Teratogenesis

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphosarcoma

Adult T-cell Leukemia/lymphoma

Leukemia, T-cell, Chronic

Antineoplastic Agents

All Drugs and Chemicals

Lenalidomide

Immunologic Factors

Angiogenesis Inhibitors

Growth Inhibitors

Among patients with relapsed or refractory adult T-cell leukemia lymphoma, patients who received Revlimid will be targeted in this surveillance

Revlimid

BMS Study Connect Contact Center www.BMSStudyConnect.com, Study manager

First line of the email MUST contain the NCT# and Site #.

Bristol-Myers Squibb

To understand the safety and efficacy of Revlimid® Capsules 2.5 mg and 5 mg (hereinafter referred to as Revlimid) under actual conditions of use in patients with relapsed or refractory adult T-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory Adult T-cell Leukemia Lymphoma (ATLL)).

1. Planned registration period 3 years
2. Planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory ATLL

Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)

Revlimid® Capsules Drug Use-results Surveillance Relapsed or Refractory Adult T-cell Leukemia Lymphoma

Number of participants with adverse events

Celgene

Esophageal Neoplasms

Pancreatic Neoplasms

Stomach Neoplasms

Esophageal Cancer

Pancreatic Cancer

Stomach Cancer

Small Intestine Cancer

Oxaliplatin

Patients that have experienced a moderate to severe hypersensitivity reaction to oxaliplatin

Jennifer A. Chan, MD, MPH

This research study will examine how often hypersensitivity, or allergic reactions, occur in patients receiving the chemotherapy medication oxaliplatin. Hypersensitivity reactions can vary from a transient skin rash and fever to more severe symptoms such as shortness of breath, chest tightness, and a more severe allergic reaction that can affect blood pressure called anaphylaxis. We will be examining how often hypersensitivity reactions occur and how severe the reactions are when they occur. We will also examine whether there are factors that place people at risk for developing hypersensitivity reactions to oxaliplatin. In an optional portion to this study, we will examine whether allergy skin testing can predict whether someone will develop a hypersensitivity reaction.

Participants who develop a moderate to severe allergic reaction to oxaliplatin will be invited to participate in an additional portion of the study examining a desensitization process. This part of the study will examine whether a desensitization process can prevent future hypersensitivity reactions to oxaliplatin in patients who previously developed moderate to severe hypersensitivity reactions and allow therapy with oxaliplatin to continue.

* Participants will come in for chemotherapy treatment as scheduled by their oncologist. The frequency of the visits will depend upon the chemotherapy regimen the participant is receiving.
* With each visit, the participants will have a physical exam and will be asked questions about their general health and specific questions about any problems that they might be having and any medications they may be taking. At each of these visits, routine blood work will be taken to monitor the participant's health.
* While the participants are receiving oxaliplatin, the infusion nurse will monitor them for any evidence of hypersensitivity reaction. Participants will also leave with a diary to record any symptoms that may occur for 24 hours after they have completed the infusion of oxaliplatin.
* In the optional portion of the study, participants will undergo allergy skin testing in the Allergy Service at Brigham and Women's Hospital The skin testing will be done at three time points: before the first dose of oxaliplatin, before the 5th dose of oxaliplatin, and before the 10th dose of oxaliplatin.
* Desensitization is a method used to help a person with an allergy tolerate exposure to a specific allergic agent. Desensitization to a medication such as oxaliplatin involves giving the medication in slowly increasing amounts, starting with tiny doses, and ending with the full dose prescribed by the physician. Patients participating in this part of the study will have the desensitization at Brigham and Women's Hospital in the Medical Intensive Care Unit (ICU or MICU) to ensure close supervision. Desensitization to oxaliplatin involves a multi-step procedure where the oxaliplatin dose is started at very small doses and the rate of infusion is increased every 15 minutes until the "target rate" is achieved. This rate is then maintained until the full dose of medication has been infused. This usually takes approximately 6 hours if no adverse reactions are experienced.

Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin

Sanofi

Dana-Farber Cancer Institute

Principal Investigator

Skin and Connective Tissue Diseases

Diseases and Abnormalities at or Before Birth

Dermatitis

Asthma

Food Hypersensitivity

Rhinitis

Rhinitis, Allergic

Dermatitis, Atopic

Eczema

Mastocytosis

Esophagitis

Eosinophilic Esophagitis

Peanut Hypersensitivity

Gastroenteritis

Respiratory Tract Diseases

Respiratory Hypersensitivity

Hypersensitivity, Immediate

Skin Diseases

Respiratory Tract Infections

Nose Diseases

Otorhinolaryngologic Diseases

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Mast Cell Activation Disorders

Eosinophilic Gastroenteritis

Kelly D Stone, M.D.

This study will evaluate and follow patients with various allergic, hypersensitivity and inflammatory disorders. The protocol is not designed to test new treatments; patients will be managed with standard of care therapies. Participants may be referred to other current NIAID protocols as appropriate or to new studies as they are developed, but will not be required to join another study.

Patients with allergic, hypersensitivity or inflammatory disorders between the ages of 3 years and 80 years may be eligible for this study. Conditions of interest include, but are not limited to, asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy.

Participants will have a medical history and physical examination, plus standard tests for diagnosing and treating their specific disorder. Tests may include routine blood and urine studies, X-rays or other imaging studies, allergy skin tests and lung function tests. Blood samples may be collected for research on immune system cells and other substances involved in immune function. Generally, about 2 to 6 tablespoons will be drawn at a time, but no more than 16 ounces will be collected over a 6-week period.

NIH does not provide emergency medical treatment or treatment for other, unrelated conditions the patient may have. Therefore, patients must maintain a personal physician for these purposes.

Allergic, hypersensitivity and inflammatory disorders, including but not limited to asthma, allergic rhinitis, mastocytosis, atopic dermatitis and food allergy are exceedingly common disorders. The pathogenesis of these various disorders are being investigated under a number of Laboratory of Allergic Diseases clinical research protocols. This protocol is an evaluation and long term follow-up protocol of such disorders, for the purposes of maintaining a group of patients on which LAD investigators draw for our other various protocols. The patients admitted under this protocol also provide training and experience for members of the NIAID Allergy and Immunology fellowship training programs.

Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders

Evaluation and Long Term Follow-up of Patients With Allergic and Inflammatory Disorders

National Institute of Allergy and Infectious Diseases (NIAID)

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Preleukemia

Leukemia, Myelomonocytic, Chronic

Leukemia, Myelomonocytic, Juvenile

Myelodysplastic Syndromes

Hematologic Neoplasms

Myeloproliferative Disorders

Aggression

Soft Tissue Neoplasms

Urticaria

Hematologic Diseases

Mastocytosis, Systemic

Leukemia, Mast-Cell

Urticaria Pigmentosa

Immune Complex Diseases

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Chronic Myelomonocytic Leukemia

Juvenile Myelomonocytic Leukemia

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Chronic Myeloproliferative Disorders

Systemic Mastocytosis

Antigen-Antibody Complex

Bezuclastinib is administered as tablets to be taken orally, continuously in 28-day cycles.

bezuclastinib

Hina Jolin, PharmD

Rachael Easton, MD, Ph.D.

This is an open-label, two-part Phase 2 study investigating CGT9486 for the treatment of patients with Advanced Systemic Mastocytosis (AdvSM), including patients with Aggressive SM (ASM), SM with Associated Hematologic Neoplasm (SM-AHN), and Mast Cell Leukemia (MCL).

There are two parts to this study, including Part I, Dose Optimization, and Part II Expansion. Part II is separated into two stages.

(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis

A Phase 2 Open-Label, Multicenter Clinical Study of the Safety, Efficacy, Pharmacokinetic, and Pharmacodynamic Profiles of CGT9486 as a Single Agent in Patients With Advanced Systemic Mastocytosis

Incidence of AEs according to CTCAE version 5.0 or higher

Percentage change in plasma concentrations of bezuclastinib

Percentage change in mast cell infiltration in the bone marrow and percentage change in eosinophilia and monocytosis in the blood

0 -10 points (higher values represent worse symptom outcomes)

0 - 7 points (higher values represent better symptom outcomes)

0 - 100 (higher values represent better symptom outcomes)

0 - 252 (higher values represent worse symptom outcomes)

Cogent Biosciences, Inc.

Warts

Hypersensitivity, Delayed

Papillomavirus Infections

Virus Diseases

DNA Virus Infections

Skin Diseases, Viral

Tumor Virus Infections

Skin Diseases, Infectious

A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.

Auto-inoculation

Waseem Shahid, MBBS

Muhammad W Shahid, MBBS

Nadia Iftikhar, MBBS, FCPS

This study is being conducted to see effectiveness of auto-inoculation of a wart in multiple viral warts. Patients with recurrent, multiple warts of all types, are being recruited for the study. A wart is excised, minced and then inoculated in a subcutaneous pocket made on the volar aspect of forearm. Patients are to be reviewed after every 4 weeks to note any reduction in number warts.

Auto-inoculation of a Wart in Multiple Viral Warts

Effectiveness of Auto-inoculation of a Wart in Multiple Viral Warts, in Tertiary Care Hospital : A Single Arm Study

All the warts on any part of the body are cleared

Pak Emirates Military Hospital

Resident Dermatology

Acute Kidney Injury

Depression

Multiple Myeloma

Neoplasms, Plasma Cell

Pneumonia

Jaundice

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hemorrhagic Disorders

Pomalidomide

Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance.

Jinshu Cho

1. Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained.
2. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Bezuclastinib will be administered orally, once daily continuously for 28-day cycles

Bezuclastinib Tablets (Formulation A)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
Prospective Analysis of Hypersensitivity Reactions to Oxaliplatin	NCT00831571	Colorectal Canc... Esophageal Canc... Gastric Cancer Small Bowel Can... Pancreatic Canc...		18 Years -	Dana-Farber Cancer Institute
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders	NCT00557895	Allergy Asthma Allergic Rhinit... Mastocytosis Atopic Dermatit... Food Allergy		3 Years - 80 Years	National Institutes of Health Clinical Center (CC)
Evaluation and Long-Term Follow-Up of Patients With Allergic and Inflammatory Disorders	NCT00557895	Allergy Asthma Allergic Rhinit... Mastocytosis Atopic Dermatit... Food Allergy		3 Years - 80 Years	National Institutes of Health Clinical Center (CC)
(Apex) Bezuclastinib in Patients With Advanced Systemic Mastocytosis	NCT04996875	Advanced System... SM With an Asso... Mast Cell Leuke... Aggressive Syst...	bezuclastinib	18 Years -	Cogent Biosciences, Inc.
Auto-inoculation of a Wart in Multiple Viral Warts	NCT04947332	Viral Wart Delayed Hyperse...	Auto-inoculatio...	-	Pak Emirates Military Hospital
Revlimid® Capsules Drug Use-results Surveillance (Relapsed or Refractory ATLL)	NCT03098589	Lymphoma	Revlimid	18 Years -	Celgene
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg	NCT02921828	Multiple Myelom...		18 Years -	Celgene
(Summit) A Study to Evaluate the Efficacy and Safety of CGT9486 Versus Placebo in Patients With Indolent or Smoldering Systemic Mastocytosis	NCT05186753	SSM Mastocytosis, I... Mastocytosis, S... Mastocytosis	Bezuclastinib T... Bezuclastinib T... Placebo Tablets	18 Years -	Cogent Biosciences, Inc.

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