- Trials with a EudraCT protocol (294)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (39)

These are paediatric studies completed by 26 January 2007, in respect of products authorised in the Community (Article 45 of the Paediatric Regulation (EC) No 1901/2006). | |
Note: Advanced search filters for country, trial phase, gender, rare disease, IMP with orphan designation in the indication and age ranges of in-utero, adult or elderly do not apply to these records. |
Study title: A a dose-escalation Phase I study in children and adolescent with relapsed or refractory leukemia. |
Active substance: arsenic trioxide |
Study summary document link (including results): Trisenox T99080.xls |
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Document reference: 47199 |
Study title: Phase II Study of Arsenic Trioxide in Neuroblastoma and other Pediatric solid tumors. |
Active substance: arsenic trioxide |
Study summary document link (including results): Trisenox CTI 1059.xls |
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Document reference: 39686 |
Study title: The CALGB study ( C9710) was designed primarily to test the hypothesis that arsenic trioxide, when added to consolidation therapy in the treatment of newly diagnosed patients, improves patients’ event-free survival in the newly diagnosed setting. In addition, this study evaluated the benefits and risks of 2 maintenance therapy regimens (ATRA versus ATRA plus mercaptopurine [6-MP]/methotrexate [MTX]), as well as the prognostic significance of CD56 expression. |
Active substance: arsenic trioxide |
Study summary document link (including results): TrisenoxCALGBC9710.xls |
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Document reference: 47200 |
Study title: Children's Cancer Group Study CCG-1961 : Asparaginase antibodies and asparaginase activity in plasma of children with acute lymphoblastic leukemia under asparaginase treatment |
Active substance: ASPARAGINASE |
Study summary document link (including results): |
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Document reference: 21882 |
Study title: COALL 82 |
Active substance: ASPARAGINASE |
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Document reference: 21883 |
Study title: COALL 85 |
Active substance: ASPARAGINASE |
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Document reference: 21884 |
Study title: COALL 89 |
Active substance: ASPARAGINASE |
Study summary document link (including results): |
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Document reference: 21885 |
Study title: COALL 92 |
Active substance: ASPARAGINASE |
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Document reference: 21886 |
Study title: COG study : Outcome of children with Bprecursor ALL registered on Pediatric Oncology Group 8602 who switched to Erwinia due to an allergy to the E.coli product |
Active substance: ASPARAGINASE |
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Document reference: 21957 |
Study title: Comparison of chemotherapy dose modifications in obese and nonobese pediatric patients with acute lymphoblastic leukemia (ALL). |
Active substance: ASPARAGINASE |
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Document reference: 21961 |
Study title: Comparison of intramuscular therapy with Erwinia asparaginase and asparaginase Medac : Pharmacokinetics, pharmacodynamics, formation of Antibodies and influence on the coagulation system |
Active substance: ASPARAGINASE |
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Document reference: 21954 |
Study title: Comparison of the efficacy of chemotherapeutic drug regimens using E.coli asparaginase or Erwinia asparaginase in childhood ALL |
Active substance: ASPARAGINASE |
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Document reference: 21960 |
Study title: DCLSG ALL-8 study: BFM-oriented treatement for children with acute lymphoblastic leukemia without cranial irradiation and treatement reduction for standard risk patients |
Active substance: ASPARAGINASE |
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Document reference: 21964 |
Study title: DFCI ALL 81-01 study : Protocols for children with newly diagnosed acute lymphoblastic leukemia |
Active substance: ASPARAGINASE |
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Document reference: 21890 |
Study title: DFCI ALL 85-01 study: Protocols for children with newly diagnosed acute lymphoblastic leukemia |
Active substance: ASPARAGINASE |
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Document reference: 21891 |
Study title: DFCI ALL 87-01 study : Protocols for children with newly diagnosed acute lymphoblastic leukemia |
Active substance: ASPARAGINASE |
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Document reference: 21892 |
Study title: DFCI ALL 91-01 study : Protocols for children with newly diagnosed acute lymphoblastic leukemia |
Active substance: ASPARAGINASE |
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Document reference: 21893 |
Study title: DFCI ALL 95-01: Protocols for children with newly diagnosed acute lymphoblastic leukemia |
Active substance: ASPARAGINASE |
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Document reference: 21920 |
Study title: Effects of glucocorticoids, E.coli-and Erwinia l-asparaginase on hemostatic proteins in children with ALL |
Active substance: ASPARAGINASE |
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Document reference: 21915 |
Study title: EORTC-CLG trial 5881: Comparison of E.coli and Erwinia asparaginase in the treatment of childhood lymphoid malignancies |
Active substance: ASPARAGINASE |
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Document reference: 21881 |