Immune System Diseases

All Conditions

Neoplasms

Blood and Lymph Conditions

Rare Diseases

Hypersensitivity

Lymphoma

Leukemia

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Leukemia, Lymphoid

Lymphoma, Non-Hodgkin

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Hematologic Diseases

Lymphosarcoma

Acute Lymphoblastic Leukemia

Lymphoblastic Lymphoma

Acute Graft Versus Host Disease

Antineoplastic Agents

All Drugs and Chemicals

Pegaspargase

Asparaginase

asparaginase Erwinia chrysanthemi

Lynda Vrooman, MD

This study will utilize Erwinaze via intravenous administration in patients between the ages of 1 and 30 who have experienced an allergy to their frontline therapy. The study will determine the proportion of patients with 2 day nadir serum asparaginase activity levels that are \>0.1 IU/mL during the first 2 weeks of treatment with 3 times per week IV dosing.

A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy

Phase II, An Open Label, Single Arm, Multi-Center Pharmacokinetic Study of Intravenous Erwinaze (Asparaginase Erwinia Chrysanthemi)Following Allergy to Native E. Coli Asparaginase (Elspar or Kidrolase), Pegaspargase (Oncaspar) or Calaspargase Pegol (EZN-2285) in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma.

To report the mean 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

To report the proportion of participants achieving 2 day NSAA levels (48 hour levels taken after the 5th dose) that are \> or = 0.1 IU/mL during the first 2 weeks of treatment with 3-times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

To report the mean 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

To report the proportion of participants achieving 3 day NSAA levels (72 hour levels taken after the 6th dose) that are \> or = 0.1 IU/mL in the first 2 weeks of treatment with 3 times per week intravenous dosing of Erwinase at 25,000 IU/m2/dose.

To describe the NSAA over time in participants with ALL/Lymphoblastic Lymphoma who have/had developed hypersensitivity to native E. coli asparaginase, Pegaspargase or Calaspargase pegol and are receiving intravenous Erwinaze 3 times per week for a prolonged duration (4-30 weeks).

Jazz Pharmaceuticals

All participants who received at least 1 dose of Erwinaze

Safety Population

All patients who received at least one dose of Erwinaze

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Director, Disclosure & Transparency

Open-Label Erwinaze

The Pharmacokinetic (PK) population consisted of all participants who received at least 1 dose of Erwinaze and were considered evaluable.

Two Day Nadir Serum Asparaginase Activity (NSAA) Level

Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 48 Hours

Three Day NSAA Level

Proportion of Participants Achieving Sustained NSAA Values of >0.1 U/mL at 72 Hours

This population consisted of participants who completed Course 4 with Pharmacokinetic(s) (PK) assessments 48 hours after dose 5 (week 8).

Nadir Serum Asparaginase Activity Over Time

Overall Study

Mouth and Tooth Diseases

Digestive System Diseases

Head and Neck Neoplasms

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Pharmaceutical Solutions

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Hormones

Caphosol

Michael Manyak, MD

Colleen Gramkowski, MST

Robert Amdur, MD

Bridgett Fitzgerald

Andy Trotti, MD

Margaret Lotrimare

Kenneth Hu, MD

David Brizel, MD

Curtis T Miyamoto, MD

Jennifer Curry, RN

Mark Chambers, MD

Andy M Trotti, MD

David M Brizel, MD

David I Rosenthal, MD

Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.

Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Michael Manyak, MD / Medical Monitor

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Erwinaze Administered Intravenously in Patients Who Had an Allergy to Frontline Asparaginase Therapy	NCT01643408	Acute Lymphobla... Lymphoblastic L...	asparaginase Er...	1 Year - 30 Years	Jazz Pharmaceuticals
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer	NCT00901732	Oral Mucositis	Caphosol	18 Years -	Jazz Pharmaceuticals

Spots Global Cancer Trial Database for eusa pharma

Every month we try and update this database with for eusa pharma 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 eusa pharma

Every month we try and update this database with for eusa pharma 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 eusa pharma 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.