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Pegaspargase and Combination Chemotherapy in Treating Younger Patients With Newly Diagnosed High-Risk Acute Lymphoblastic Leukemia (Closed to Accrual 4-22-2011)
Phase 1 trial testing Cyclophosphamide in Acute Lymphoblastic Leukemia in 104 participants. Completed in 31 March 2021.
| Lead sponsor | Children's Oncology Group |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 104 |
| Start date | 23 February 2009 |
| Primary completion | 30 June 2014 |
| Estimated completion | 31 March 2021 |
| Sites | 28 locations across Canada, United States, Australia |
Children's Oncology Group — full company profile →
Adults 1 to 30, any sex, with Acute Lymphoblastic Leukemia or Adult B 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 Group B (High Risk-High) patients taking less than 49 weeks from day 1 of consolidation to day 1 of maintenance therapy. Only Group B analyzed since this is prespecified in protocol.
| Group | Value | 95% CI |
|---|---|---|
| Group B (High Risk-High) | 50.0 | 35.6 – 64.4 |
Percentage of Group B (High Risk-High) patients that tolerate at least 8 of the 12-14 total doses of pegaspargase during Consolidation, Interim Maintenance, and Delayed Intensification periods. Only Grp B analyzed since this is prespecified in protocol.
| Group | Value | 95% CI |
|---|---|---|
| Group B (High Risk-High) | 53.3 | 38.7 – 67.4 |
Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Induction | Group A (High Risk-Average) | Group B (High Risk-High) |
|---|---|---|---|---|
| Infections and infestations - Other, specify | Infections and infestations | — | — | — |
| Nervous system disorders - Other, specify | Nervous system disorders | — | — | — |
| Seizure | Nervous system disorders | — | — | — |
| Hypotension | Vascular disorders | — | — | — |
| Intracranial hemorrhage | Nervous system disorders | — | — | — |
| Thromboembolic event | Vascular disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Cardiac arrest | Cardiac disorders | — | — | — |
| Cardiac disorders - Other, specify | Cardiac disorders | — | — | — |
| Colitis | Gastrointestinal disorders | — | — | — |
| Depressed level of consciousness | Nervous system disorders | — | — | — |
| Disseminated intravascular coagulation | Blood and lymphatic system disorders | — | — | — |
| Dysphasia | Nervous system disorders | — | — | — |
| Fibrinogen decreased | Investigations | — | — | — |
| Hepatic hemorrhage | Hepatobiliary disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Investigations - Other, specify | Investigations | — | — | — |
| Multi-organ failure | General disorders | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Syncope | Nervous system disorders | — | — | — |
| Typhlitis | Gastrointestinal disorders | — | — | — |
| Reaction | System | Induction | Group A (High Risk-Average) | Group B (High Risk-High) |
|---|---|---|---|---|
| Neutrophil count decreased | Investigations | — | — | — |
| Infections and infestations - Other, specify | Infections and infestations | — | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — | — |
| Alanine aminotransferase increased | Investigations | — | — | — |
| White blood cell decreased | Investigations | — | — | — |
| Platelet count decreased | Investigations | — | — | — |
| Anemia | Blood and lymphatic system disorders | — | — | — |
| Hyperglycemia | Metabolism and nutrition disorders | — | — | — |
| Aspartate aminotransferase increased | Investigations | — | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — | — |
| Hyponatremia | Metabolism and nutrition disorders | — | — | — |
| Peripheral motor neuropathy | Nervous system disorders | — | — | — |
| Blood bilirubin increased | Investigations | — | — | — |
| Anaphylaxis | Immune system disorders | — | — | — |
| Hypokalemia | Metabolism and nutrition disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Fibrinogen decreased | Investigations | — | — | — |
| Hypocalcemia | Metabolism and nutrition disorders | — | — | — |
| Allergic reaction | Immune system disorders | — | — | — |
| Lipase increased | Investigations | — | — | — |
| Lung infection | Infections and infestations | — | — | — |
| Mucositis oral | Gastrointestinal disorders | — | — | — |
| Avascular necrosis | Musculoskeletal and connective tissue disorders | — | — | — |
| GGT increased | Investigations | — | — | — |
| Hypoalbuminemia | Metabolism and nutrition disorders | — | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — | — |
| Hyperkalemia | Metabolism and nutrition disorders | — | — | — |
| Vascular access complication | Injury, poisoning and procedural complications | — | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Hypophosphatemia | Metabolism and nutrition disorders | — | — | — |
| Pancreatitis | Gastrointestinal disorders | — | — | — |
| Enterocolitis infectious | Infections and infestations | — | — | — |
| Upper respiratory infection | Infections and infestations | — | — | — |
| Weight loss | Investigations | — | — | — |
| Fever | General disorders | — | — | — |
| Glucose intolerance | Metabolism and nutrition disorders | — | — | — |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Seizure | Nervous system disorders | — | — | — |
| Serum amylase increased | Investigations | — | — | — |
Most-reported serious reactions: Infections and infestations - Other, specify, Nervous system disorders - Other, specify, Seizure, Hypotension, Intracranial hemorrhage, Thromboembolic event, Alanine aminotransferase increased, Blood bilirubin increased.
Data from ClinicalTrials.gov NCT00866307 adverse events section.
This pilot clinical trial studies the side effects of pegaspargase when given together with combination chemotherapy in treating patients with newly diagnosed high-risk acute lymphoblastic leukemia. Pegaspargase may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) together with pegaspargase may kill more cancer cells.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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