N/A
N=59
Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
Adult Acute Lymphoblastic Leukemia · Childhood Acute Lymphoblastic Leukemia
Bottom Line
View on ClinicalTrials.gov: NCT00537030 ↗Enrolled (actual)
59
Serious AEs
16.4%
Results posted
Aug 2014
Primary outcome: Primary: Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL — 94.5 Percent of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Asparaginase (Drug); Laboratory Biomarker Analysis (Other); Pharmacological Study (Other)
- Age
- Pediatric, Adult · 1+ yrs
- Sex
- All
- Sponsor
- Children's Oncology Group
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Trough Serum Asparaginase Activity ≥ 0.1 IU/mL |
94.5 | — |
| SECONDARY Determine if Plasma Asparagine is Adequately Depleted |
— | — |
| SECONDARY Presence of Anti-Erwinia Asparaginase Antibodies in Children Treated With a Course(s) of Erwinase® Following Clinical Allergy to PEG-asparaginase |
— | — |
| SECONDARY Percentage of Participants Who Experienced Toxicities |
10.9; 10.9; 1.8; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of acute lymphoblastic leukemia
- Concurrently enrolled on a frontline Children's Oncology Group treatment trial (i.e., COG-AALL0232 or COG-AALL0531, COG-AALL0331, or COG-AALL0434) at a participating institution
- Must have 1 or more courses of asparaginase remaining to be administered on the treatment protocol
- Must have had a grade ? 2 hypersensitivity reaction to PEG-asparaginase
- No history of pancreatitis ? grade 2
- No prior Erwinia asparaginase
Data sourced from ClinicalTrials.gov (NCT00537030). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.