Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Rare Diseases

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Hypersensitivity

Lymphoma

Neoplasms by Histologic Type

Hematologic Diseases

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Lymphosarcoma

Anti-Inflammatory Agents

Antineoplastic Agents

Antiemetics

Gastrointestinal Agents

All Drugs and Chemicals

Anti-Infective Agents

Antirheumatic Agents

Dermatologic Agents

Reproductive Control Agents

Cardiotonic Agents

Micronutrients

Hematinics

Vitamins

Dexamethasone

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Cytarabine

Doxorubicin

Liposomal doxorubicin

Methotrexate

Vincristine

Dexamethasone acetate

BB 1101

Asparaginase

Dexrazoxane

Razoxane

Dexamethasone 21-phosphate

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

HIV Protease Inhibitors

Protease Inhibitors

Enzyme Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Antimetabolites

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Immunosuppressive Agents

Immunologic Factors

Antiviral Agents

Tubulin Modulators

Antimitotic Agents

Protective Agents

Folinic Acid

Folate

Vitamin B9

All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.

The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.

Erwinase will be administered as a 2-hour intravenous infusion.

Erwinase

1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22

10 mg/m2/day divided BID. Give by mouth days 1-14.

Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3 and older

Given Intrathecally to all patients who are CNS 1 or 2 at study entry. Dose defined by age. Given on day 15 8mg for age 1-1.99 10 mg for age 2-2.99 12 mg for age 3-8.99 15 mg for age 9 and older

Methotrexate, Cytarabine and Hydrocortisone given Intrathecally on day 8, 15 and 22 for patients who are CNS 3 at study entry. Doses determined by age.

Triple Intrathecal Therapy

Due to the limited availability of Dexrazoxane (Zinecard®), treatment will be at the discretion of the treating physician. Dose should be 600 mg/m2 as a IV push immediately prior to anthracycline dose (the elapsed time from the beginning of the dexrazoxane dose to the end of the anthracycline infusion should be 30 minutes or less).

Heather Grossman, MD

Paul Gaynon, MD

This is a phase I study using the Erwinia form of asparaginase in place of the E. coli form using a standard re-induction regimen (Vincristine, Dexamethasone, Doxorubicin) for patients with relapsed ALL who have developed an allergy to the E. coli formulation. This study will administer the drug intravenously instead of the usual intramuscular route. The dose of Erwinia will be escalated in the absence of dose limiting toxicity. Patients must have first or second relapse ALL with a history of prior systemic reaction to E. coli asparaginase.

Significance

1. Substitution of Erwinase after E.coli asparaginase allergy has been standard practice despite the paucity of evidence regarding its efficacy and uncertainty about dose. Definition of an appropriate dose and schedule of Erwinase that provides reliable asparagine depletion may be useful for patients with clinical allergy to E. coli asparaginase, both in first remission or after relapse.
2. Patients in relapse may have a different level of asparagine synthesis than patients maintaining remission and require different asparaginase dosing.5
3. Intravenous administration provides more rapid and predictable asparagine depletion with less discomfort and danger of bleeding for often thrombocytopenic patients than intramuscular administration.
4. Vincristine, doxorubicin, asparaginase, and dexamethasone with dexrazoxane is clinically relevant for a population with first marrow relapse.
5. Vincristine, doxorubicin, asparaginase, and dexamethasone with dexrazoxane is clinically relevant for a population with second marrow relapse, if the duration of CR2 \> 18 months year.

Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)

Intravenous Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia and Allergy to E. Coli Asparaginase (IND 104224)

The MTD in each stratum will be the highest dose at which 1 or fewer of six patients experience DLT during cycle 1 of therapy.

Disease response evaluated by examination and labs. MRD evaluated from marrow samples.

Activity levels assessed from PK sampling

Therapeutic Advances in Childhood Leukemia Consortium

The definition of AE and SAE do not differ from the clinicaltrials.gov definitions.

All patients receive Vincristine, Dexamethasone, Doxorubicin, and Cytarabine. Dexrazoxane optional on Day 1. Erwinase is started between Days 3-5 and is given every M-W-F for a total of 10 doses. Patients with CNS 1 or 2 receive Methotrexate intrathecally on Day 15. Patients with CNS 3 receive Triple Intrathecal Therapy (Methotrexate, Cytarabine and Hydrocortisone) on Days 8, 15, and 22.

Erwinase: The dose of Erwinase will be assigned at study entry. The first dose of Erwinase wil be given between Days 3-5 and will continue on a M-W-F schedule for a total of 10 doses.

Erwinase will be administered as a 2-hour intravenous infusion.

Vincristine: 1.5 mg/m2/dose IV push (maximum single dose 2 mg) on Days 1, 8, 15 and 22

Dexamethasone: 10 mg/m2/day divided BID. Give by mouth days 1-14.

Doxorubicin: 60 mg/m2/day IV over 15 minutes on day 1

Cytarabine: Given Intrathecally at the dose defined by age on day 1. 30 mg for age 1-1.99 50 mg for age 2-2.99 70 mg for age 3

Single Arm

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

The study closed early due to lack of accrual and insufficient funding. Only one patient was enrolled. This patient completed the protocol therapy.

Peggy Romano, BA, CCRP

Occurrence of a Dose-Limiting Toxicity

Study closed early due to lack of accrual, and insufficient data were collected for performing this analysis.

Response Rate and Minimum Residual Disease

Study closed early due to lack of accrual and insufficient data were collected to perform this analysis.

Asparaginase Activity

Overall Study

Skin and Connective Tissue Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Infections

Ear, Nose, and Throat Diseases

Diseases and Abnormalities at or Before Birth

Digestive System Diseases

Symptoms and General Pathology

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

Communicable 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)

Syndrome

Anaphylaxis

Urticaria

Mast Cell Activation Syndrome

Chronic Urticaria

Skin Diseases, Vascular

Chronic Disease

Disease Attributes

Chronic Graft Versus Host Disease

Tak H Lee

Activation of mast cells in the immune system is known to cause allergic reactions sometimes with severe systemic symptoms. The investigators have recently developed a blood-based mast cell activation diagnostic test in which levels of functional activation in-vitro in primary cultured mast cells generated from the peripheral blood of single individuals can be assessed. It is the hypothesis that the test can be used to predict the potential state of in-vivo mast cell activation in any individual based on the functional activation profiles exhibited by their cultured mast cells. The investigators now wish to translate their in-vitro findings in a pilot study to disease groups where mast cell activation is expected to be high. These include highly allergic individuals; those with chronic idiopathic urticaria; those with mastocytosis; and those with the mast cell activation syndrome. Furthermore, they will use the functional genomics approach to identify gene expression biomarkers that are correlated with such diseases. The results will be compared with data that have been collected from a cohort of healthy control blood donors.

The objective of this study is to assess whether patients with severe allergic diseases exhibit high levels of mast cell activation as determined by the mast cell activation diagnostic test the investigators have developed. They anticipate that patients with history of severe allergic reactions will show up as high responders in the blood-based mast cell activation diagnostic test. Moreover, using microarray analysis as the approach for gene expression studies, they anticipate further that genomics biomarkers that are correlated with the high functional activation of the in-vitro mast cells derived from these patients can be readily identified.

About 100 ml of peripheral venous blood from individual patients will be drawn into heparinized syringes and collected in a blood-collecting bag/tube containing silica. The bag/tube will be promptly processed for the generation of primary human mast cell cultures using the protocol that has previously been developed \[Inflammation Research 66: 25 (2017). After culturing for 9 weeks, the resulting human mast cells will be analyzed for both their functional activity in terms of histamine release in response to the activation of high-affinity Immunoglobulin E (IgE) receptors in these cells and their gene expression profiles using microarray analysis. The in-vitro functional and genomics data will be correlated with specific diagnoses and measurements of blood prostaglandin D2 (PGD2), PGD2 metabolites, tryptase and histamine levels in blood. For mediator assays, plasma from each subject will be collected after the cluster of differentiation 34 positive (CD34+) isolation step and the samples will be aliquoted and frozen at -80 degrees centigrade for subsequent analysis.

Mast Cell Activation Test in Allergic Disease

Assessment of Mast Cell Activation Diagnostic Test in Patients With Allergic Disease

Mast Cell Activation Test results of high/low level of house dust mite sensitivity by using normal donor cultured mast cells for validation.

Patient's serum was incubated with mast cells derived from normal donors for detection of mast cell activation as evidenced by histamine release.

percentage of total histamine release by normal average responder mast cells that had been activated with patient's serum

percentage of total histamine release by patient's mast cells that had been activated with anti-IgE

Percentage of total histamine release when patient's mast cells were activated with patient's own serum and Der p2. Each patient's results are reported individually.

Cell yield of patient's mast cell culture after 9 weeks in culture as an index of cell growth and differentiation.

Chinese University of Hong Kong

Stanford University

Hong Kong Sanatorium & Hospital

Director Allergy Centre

Mast cell activation test employing normal donor cultured mast cells and allergic patient serum samples

Validation Group

Male patient, Total IgE: 28918KU/L; Der p2IgE: 64.4KU/L; clinical diagnosis: Eczema

SH#1

Male patient, Total IgE: 22311KU/L; Der p2IgE: 91.24KU/L; clinical diagnosis: Eczema

SH#2

Female patient, Total IgE: 5333KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema

SH#3

Male patient, Total IgE: 4070KU/L; Der p2IgE: \>100KU/L; clinical diagnosis: Eczema, Urticaria

SH#4

Male patient, Total IgE: 379KU/L; Der p2IgE: 0.15KU/L; clinical diagnosis: Exercise-induced anaphylaxis

SH#5

Female patient, Total IgE: 13KU/L; Der p2IgE: \<0.1KU/L; clinical diagnosis: Mast cell activation syndrome

SH#6

Male patient, Total IgE: 67KU/L; Der p2IgE: None KU/L; clinical diagnosis: Urticaria

SH#7

Total

Hong Kong

Region of Enrollment

Clinical diagnosis of participants before Mast cell activation test

Clinical diagnosis

During recruitment period, no participants with asthma, food allergy, mastocytosis were recruited.

Prof. Tak Hong Lee

High level of house dust mite sensitivity

Low level of house dust mite sensitivity

Mast cells were cultured from blood of normal donors to validate the (Mast Cell Activation) MAT assay. The serum samples were obtained from allergic patients with sensitivities to Der p2 and used for passive sensitization of normal donor mast cells followed by their activation by Der p2 allergen. Data were collected only from the validation group.

Mast Cell Activation Test Results for Validation Group

Male patient, Total IgE: 28918 KU/L; Der p2 IgE: 64.4 KU/L; clinical diagnosis: Eczema

Male patient, Total IgE: 22311 KU/L; Der p2 IgE: 91.24 KU/L; clinical diagnosis: Eczema

Female patient, Total IgE: 5333 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema

Male patient, Total IgE: 4070 KU/L; Der p2 IgE: \>100 KU/L; clinical diagnosis: Eczema, Urticaria

Male patient, Total IgE: 379 KU/L; Der p2 IgE: 0.15 KU/L; clinical diagnosis: Exercise-induced anaphylaxis

Female patient, Total IgE: 13 KU/L; Der p2 IgE: \<0.1 KU/L; clinical diagnosis: Mast cell activation syndrome

Male patient, Total IgE: 67 KU/L; Der p2 IgE: None KiloUnits (KU)/L; clinical diagnosis: Urticaria

Serum samples were obtained from 19 patients in total, of whom 12 were in the validation group. The other 7 patients were studied more extensively in the trial and their data is reported individually in this section and thereafter.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erwinase for Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (IND 104224)	NCT00928200	Relapsed Acute ... Allergy to PEG ... Allergy to Nati...	Erwinase Vincristine Dexamethasone Doxorubicin Cytarabine Methotrexate Triple Intrathe... Dexrazoxane	1 Year - 21 Years	Therapeutic Advances in Childhood Leukemia Consortium
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)
Mast Cell Activation Test in Allergic Disease	NCT03406325	Asthma Mastocytosis Mast Cell Activ... Food Allergy Chronic Idiopat... Anaphylaxis Eczema		18 Years -	Hong Kong Sanatorium & Hospital
Mast Cell Activation Test in Allergic Disease	NCT03406325	Asthma Mastocytosis Mast Cell Activ... Food Allergy Chronic Idiopat... Anaphylaxis Eczema		18 Years -	Hong Kong Sanatorium & Hospital
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)

Spots Global Cancer Trial Database for allergy

Every month we try and update this database with for allergy 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 allergy

Every month we try and update this database with for allergy 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 allergy 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.