Other Clinical Trial - Erwinia Asparaginase After Allergy to

Status Completed

Clinical Trial Summary

This clinical trial is studying the side effects of Erwinia asparaginase and what happens to the drug in the body in treating young patients with acute lymphoblastic leukemia who are allergic to PEG-asparaginase. Drugs used in chemotherapy, such as Erwinia asparaginase, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing.

Clinical Trial Description

PRIMARY OBJECTIVES:

I. To determine if the 48-hour trough serum asparaginase activity is ? 0.1 IU/mL in young patients with acute lymphoblastic leukemia treated with Erwinia asparaginase after allergy to PEG-asparaginase.

II. To determine the frequency of asparaginase-related toxicity in these patients.

III. To characterize the pharmacokinetics of Erwinia asparaginase in these patients.

SECONDARY OBJECTIVES:

I. To compare serum asparaginase activity and serum asparagine concentration between patients treated with Erwinia asparaginase on this trial and historical controls treated with PEG-asparaginase on CCG-1961 and CCG-1962.

II. To determine the 72-hour serum asparaginase activity on days 8 or 11 or 13 based on the starting date of Erwinia asparaginase therapy.

III. To determine the presence of anti-Erwinia asparaginase antibodies in patients treated with a course(s) of Erwinia asparaginase following clinical allergy to PEG-asparaginase (PEG, pegaspargase).

IV. To determine if serum asparagine is adequately depleted on days 12 or 13 in a subset of these patients.

OUTLINE: This is a multicenter study.

Patients receive 6 doses of Erwinia asparaginase intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.

Blood samples are collected periodically for pharmacokinetic, pharmacodynamic, and antibody studies.

After completion of study treatment, patients are followed periodically. ;

Study Design

Related Conditions & MeSH terms

Adult Acute Lymphoblastic Leukemia
Childhood Acute Lymphoblastic Leukemia
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma

Clinical Trial Details

NCT number	NCT00537030
Study type	Interventional
Source	Children's Oncology Group
Contact
Status	Completed
Phase	N/A
Start date	February 11, 2008

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT04541056` - Goal Management Training for Adult Survivors of Childhood Leukemia and Non-Hodgkins Lymphoma With Neurocognitive Sequelae	N/A
Recruiting	`NCT01990807` - Treatment Protocol of Children With Philadelphia Chromosome Negative High Risk Acute Lymphoblastic Leukemia	Phase 4
Completed	`NCT00898079` - Collecting and Storing Malignant, Borderline Malignant Neoplasms, and Related Samples From Young Patients With Cancer
Recruiting	`NCT03390387` - Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2015 (ALL-MB 2015)	N/A
Withdrawn	`NCT01492569` - Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting	N/A
Recruiting	`NCT05452668` - Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients	N/A
Recruiting	`NCT05729178` - Unravelling the Role of KCTD Protein Family in the Clinical Management of Childhood Acute Lymphoblastic Leukemias
Recruiting	`NCT03981510` - Comparison of Gastrointestinal Motility in Healthy Children and Children With Constipation	N/A
Completed	`NCT01150669` - Lestaurtinib With or Without Chemotherapy Agents in Samples From Young Patients With Leukemia	N/A
Active, not recruiting	`NCT01953770` - Childhood Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2008	N/A
Completed	`NCT00674193` - Evaluating Dactinomycin and Vincristine in Young Patients With Cancer	N/A
Recruiting	`NCT04723342` - Acute Lymphoblastic Leukemia Treatment Protocol Moscow-Berlin 2019 Pilot	N/A
Completed	`NCT01251575` - Sirolimus, Cyclosporine, and Mycophenolate Mofetil in Preventing Graft-versus-Host Disease in Treating Patients With Blood Cancer Undergoing Donor Peripheral Blood Stem Cell Transplant	Phase 2
Recruiting	`NCT04626765` - CAR-T for Children With Relapsed and Refractory Acute Lymphoblastic Leukemia	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms