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| ID | Type | Description | Link |
|---|---|---|---|
| EudraCT number 2006-003180-31 |
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This multicentric phase III study is designed to assess the efficacy and safety of recombinant asparaginase (rASNase) in comparison to Asparaginase medac™ during treatment of children with de novo ALL
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| asparaginase medac | Active Comparator |
| |
| recombinant asparaginase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| asparaginase | Drug | 5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the rate of patients with complete asparagine (ASN) depletion in serum during induction treatment and to demonstrate non-inferiority of rASNase compared to Asparaginase medac™ with respect to this parameter | March 2012 |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the incidence of patients with hypersensitivity reactions to the first dose of ASNase in the post-induction treatment | March 2012 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Erasmus MC | Rotterdam | NL-3015 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29727043 | Derived | van der Sluis IM, de Groot-Kruseman H, Te Loo M, Tissing WJE, van den Bos C, Kaspers GJL, Bierings M, Kollen WJW, Konig T, Pichlmeier U, Kuhnel HJ, Pieters R. Efficacy and safety of recombinant E. coli asparaginase in children with previously untreated acute lymphoblastic leukemia: A randomized multicenter study of the Dutch Childhood Oncology Group. Pediatr Blood Cancer. 2018 Aug;65(8):e27083. doi: 10.1002/pbc.27083. Epub 2018 May 4. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D001215 | Asparaginase |
| C000718243 | asparaginase erwinia chrysanthemi recombinant |
| ID | Term |
|---|---|
| D000581 | Amidohydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
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| recombinant asparaginase |
| Drug |
5.000U /m²; IV; day 12, 15, 18, 21, 24, 27, 30, 33 |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |