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SC-PEG Asparaginase vs. Oncaspar in Pediatric Acute Lymphoblastic Leukemia (ALL) and Lymphoblastic Lymphoma
Condition: Acute Lymphoblastic Leukemia · Lymphoblastic Lymphoma · Sponsor: Dana-Farber Cancer Institute
About this study
This study is being conducted to learn about the effects of SC-PEG, which is a new form of a chemotherapy drug called asparaginase. Asparaginase is used to treat ALL and lymphoblastic lymphoma. The standard form of asparaginase, called Elspar, is given in the muscle once a week for 30 weeks. There are other forms of asparaginase. The investigators will be studying two of these: Oncaspar and Calaspargase Pegol (SC-PEG). The investigators have previously studied giving Oncaspar in the vein (instead of the muscle) every 2 weeks in patients with ALL, and have shown that this dosing did not lead to any more side effects than Elspar given weekly in the muscle. The study drug, SC-PEG, is very similar but not identical to Oncaspar. SC-PEG has been given in the vein to children and adolescents with ALL as part of other research studies, and it appears to last longer in the blood after a dose than Oncaspar. It has not yet been approved by the FDA. The goal of this research study is to learn whether the side effects and drug levels of SC-PEG given in the vein every 3 weeks are similar to Oncaspar given into the vein about every 2 weeks. The study will also help to determine whether changing treatment for children and adolescents with ALL with high levels of minimal residual disease may improve cure rates. Measuring minimal disease (MRD) is a laboratory test that finds low levels of leukemia cells that the investigators cannot see under the microscope. In the past, it has been shown tha…
This description comes directly from the study's public registry record.
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Locations (8)
| Children's Hospital Boston | Boston, Massachusetts, United States | — |
| Dana-Farber Cancer Institute | Boston, Massachusetts, United States | — |
| Columbia University Medical Center, Morgan Stanley Children's Hospital of New York-Presbyterian | New York, New York, United States | — |
| Montefiore Medical Center | New York, New York, United States | — |
| Hasbro Children's Hospital | Providence, Rhode Island, United States | — |
| McMaster University | Hamilton, Ontario, Canada | — |
| Hospital Sainte Justine, University of Montreal | Montreal, Quebec, Canada | — |
| Centre Hospitalier U. de Quebec | Québec, Quebec, Canada | — |
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Source record: clinicaltrials.gov/study/NCT01574274