- Trials with a EudraCT protocol (432)
- Paediatric studies in scope of Art45 of the Paediatric Regulation (68)

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 multi-centre, double-blind, controlled trial of prophylaxis against cytomegalovirus infections in bone marrow transplant patients using intravenous acyclovir followed by oral acyclovir. |
Active substance: ACICLOVIR |
Study summary document link (including results): Study H14-304 Aciclovir.xls |
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Document reference: 46215 |
Study title: PROPHYLAXIS AGAINST CMV IN BONE MARROW TRANSPLANT RECIPIENTS WITH INTRAVENOUS ZOVIRAX |
Active substance: ACICLOVIR |
Study summary document link (including results): Study ZOVlRAX#142 Aciclovir.xls |
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Document reference: 46212 |
Study title: Dalieri M, Gnius A, Gómez S, Pernas J, Fabeiro M, Prozzi M: Uso de L-glutamina en niños con transplante de modula ósea / Glutamine use in children with bone marrow transplantation. RNC 2003; 12: 54-59 abstract (language Spanish)Dalieri M, Gnius A, Gómez S, Pernas J, Fabeiro M, Prozzi M: Uso de L-glutamina en niños con transplante de modula ósea / Glutamine use in children with bone marrow transplantation. RNC 2003; 12: 54-59 abstract (language Spanish) |
Active substance: ALANYL-GLUTAMINE |
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Document reference: 46315 |
Study title: POG 9407 Study I : induction intensification and allogeneic bone marrow transplant in infant ALL |
Active substance: ASPARAGINASE |
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Document reference: 21930 |
Study title: Suttorp M et al, Fractionated total body irradiation plus high-dose VP-16 prior to allogeneic bone marrow transplantation in children with poor risk acute leukaemias, Bone Marrow Transplant. 1989 Dec;4 Suppl 4:144-8 |
Active substance: ETOPOSIDE |
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Document reference: 26906 |
Study title: Santana VM et al Escalating sequential high-dose carboplatin and etoposide with autologous marrow support in children with relapsed solid tumors Bone Marrow Transplant 1992 Nov;10(5):457-62 |
Active substance: ETOPOSIDE |
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Document reference: 26750 |
Study title: Santana VM et al, Escalating sequential high-dose carboplatin and etoposide with autologous marrow support in children with relapsed solid tumors, Bone Marrow Transplant 1992 Nov;10(5):457-62 |
Active substance: ETOPOSIDE |
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Document reference: 26804 |
Study title: Gonzalez-Vicent, M., Madero, L., Sevilla, J., et al, Ramirez, M. and Diaz, M. A. A prospective randomized study of clinical and economic consequences of using G-CSF following autologous peripheral blood progenitor cell (PBPC) transplantation in children Bone Marrow Transplantation 34(12): 1077-1081. |
Active substance: ETOPOSIDE |
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Document reference: 26958 |
Study title: Duerst RE et al, Allogeneic bone marrow transplantation for children with acute leukemia:, cytoreduction with fractionated total body irradiation, high-dose etoposide and, cyclophosphamide, Bone Marrow Transplant. 2000 Mar;25(5):489-94 |
Active substance: ETOPOSIDE |
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Document reference: 26880 |
Study title: Bisogno G et al Intensive chemotherapy for children and young adults with metastatic primitive neuroectodermal tumors of the soft tissue.Bone Marrow Transplant 2002 Sep;30(5):297-302 |
Active substance: ETOPOSIDE |
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Document reference: 26689 |
Study title: Bouffet E et al, Etoposide and thiotepa followed by ABMT (autologous bone marrow transplantation) in children and young adults with high-grade gliomas, Eur J Cancer. 1997 Jan;33(1):91-5 |
Active substance: ETOPOSIDE |
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Document reference: 26840 |
Study title: Zucker JM et al , Single or double consolidation treatment according to remission status after initial therapy in metastatic neuroblastoma: first results of LMCE 3 study in 40 patients, Bone Marrow Transplant. 1991;7 Suppl 2:91. No abstract available |
Active substance: ETOPOSIDE |
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Document reference: 26954 |
Study title: Petersen FB et al, Etoposide, cyclophosphamide and fractionated total body irradiation as a preparative regimen for marrow transplantation in patients with advanced hematological malignancies: a phase I study, Bone Marrow Transplant. 1992 Jul;10(1):83-8 |
Active substance: ETOPOSIDE |
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Document reference: 26894 |
Study title: Bunin N et al, Randomized trial of busulfan vs total body irradiation containing conditioning regimens for children with acute lymphoblastic leukemia: a Pediatric Blood and Marrow Transplant Consortium study, Bone Marrow Transplant. 2003 Sep;32(6):543-8 |
Active substance: ETOPOSIDE |
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Document reference: 26873 |
Study title: Kang HJ et al, Autologous peripheral blood stem cell transplantation with BCVAC conditioning in , childhood acute myeloid leukemia, Bone Marrow Transplant. 2004 Mar;33(5):471-6 |
Active substance: ETOPOSIDE |
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Document reference: 26887 |
Study title: Valteau-Couanet D et al, Phase I study of high-dose continuous intravenous infusion of VP-16 in, combination with high-dose melphalan followed by autologous bone marrow transplantation in children with stage IV neuroblastoma, Bone Marrow Transplant. 1996 Apr;17(4):485-9 |
Active substance: ETOPOSIDE |
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Document reference: 26947 |
Study title: von Bueltzingsloewen A et al, Allogeneic bone marrow transplantation following a busulfan-based conditioning regimen in young children with acute lymphoblastic leukemia: a Cooperative Study of the Société Française de Greffe de Moelle, Bone Marrow Transplant. 1995 Oct;16(4):521-7 |
Active substance: ETOPOSIDE |
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Document reference: 26908 |
Study title: Boenig, H., Silbermann, S., Weller, S., et al. Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF): Results of a prospective randomised monocentre study Bone Marrow Transplantation 28(3): 259-264.Boenig, H., Silbermann, S., Weller, S., et al. Glycosylated vs non-glycosylated granulocyte colony-stimulating factor (G-CSF): Results of a prospective randomised monocentre study Bone Marrow Transplantation 28(3): 259-264. |
Active substance: FILGASTRIM |
Study summary document link (including results): Bibliography - Neupogen[2].pdf |
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Document reference: 27275 |
Study title: Fleischhack, G., Hasan, C., Graf, N., et al. IDA-FLAG (idarubicin, fludarabine, cytarabine, G-CSF), an effective remission-induction therapy for poor-prognosis AML of childhood prior to allogeneic or autologous bone marrow transplantation: Experiences of a phase II trial British Journal of Haematology 102(3): 647-655.Fleischhack, G., Hasan, C., Graf, N., et al. IDA-FLAG (idarubicin, fludarabine, cytarabine, G-CSF), an effective remission-induction therapy for poor-prognosis AML of childhood prior to allogeneic or autologous bone marrow transplantation: Experiences of a phase II trial British Journal of Haematology 102(3): 647-655. |
Active substance: FILGASTRIM |
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Document reference: 27281 |
Study title: EFFICACY AND TOLERATION OF AN ANTIFUNGAL PROPHYLAXIS OF FLUCONAZOLE IN PATIENTS HAVING UNDERGONE BONE MARROW TRANSPLANTATION. |
Active substance: FLUCONAZOLE |
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Document reference: 27425 |