Last reviewed · How we verify
Erwinia Asparaginase After Allergy to PEG-Asparaginase in Treating Young Patients With Acute Lymphoblastic Leukemia
NA trial testing Asparaginase in Adult Acute Lymphoblastic Leukemia in 59 participants. Completed.
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 59 |
| Start date | 11 February 2008 |
| Primary completion | 1 February 2011 |
| Sites | 43 locations across United States |
Children's Oncology Group — full company profile →
Adults 1 to 30, any sex, with Adult Acute Lymphoblastic Leukemia or Childhood Acute Lymphoblastic Leukemia. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of participants who had trough serum asparaginase activity ≥ 0.1 IU/mL in the blood 48 hours post administration of Erwinia asparaginase
| Group | Value | 95% CI |
|---|---|---|
| Erwinia Asparaginase | 94.5 |
The percentage of participants who experienced toxicities: Allergy rate, Hyperglycemia Rate, Pancreatitis Rate, Hemorrhage/Thrombosis Rate
| Group | Value | 95% CI |
|---|---|---|
| Erwinia Asparaginase | 10.9 |
| Group | Value | 95% CI |
|---|---|---|
| Erwinia Asparaginase | 10.9 |
| Group | Value | 95% CI |
|---|---|---|
| Erwinia Asparaginase | 1.8 |
| Group | Value | 95% CI |
|---|---|---|
| Erwinia Asparaginase | 0 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Erwinia Asparaginase |
|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Allergic reaction | Immune system disorders | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Fever | General disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Neutrophil count decreased | Investigations | — |
| Platelet count decreased | Investigations | — |
| White blood cell decreased | Investigations | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Reaction | System | Erwinia Asparaginase |
|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Allergic reaction | Immune system disorders | — |
| Alanine aminotransferase increased | Investigations | — |
| Aspartate aminotransferase increased | Investigations | — |
| Blood bilirubin increased | Investigations | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — |
| Vomiting | Gastrointestinal disorders | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — |
| Nausea | Gastrointestinal disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Fatigue | General disorders | — |
| Radiation recall reaction (dermatologic) | Injury, poisoning and procedural complications | — |
| Lipase increased | Investigations | — |
| Headache | Nervous system disorders | — |
| Agitation | Psychiatric disorders | — |
| Urticaria | Skin and subcutaneous tissue disorders | — |
Most-reported serious reactions: Infections and infestations - Other, specify, Aspartate aminotransferase increased, Allergic reaction, Febrile neutropenia, Fever, Alanine aminotransferase increased, Blood bilirubin increased, Neutrophil count decreased.
Data from ClinicalTrials.gov NCT00537030 adverse events section.
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.
3 peer-reviewed publications reference this trial (live from Europe PMC):
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
Trials by the same sponsor.
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00537030.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing