Risk adapted treatment of acute myelocytic leukemia (AML).
- Conditions
- Acute myelocytic leukemia.
- Registration Number
- NL-OMON27294
- Lead Sponsor
- Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON) P/a HOVON Data CenterErasmus MC - Daniel den HoedPostbus 52013008 AE RotterdamTel: 010 4391568Fax: 010 4391028e-mail: hdc@erasmusmc.nl
- Brief Summary
1. G.E. de Greef, W.L. van Putten, M. Boogaerts, P.C. Huijgens, L.F. Verdonck, E. Vellenga, M. Theobald, E. Jacky and B. Löwenberg; The Dutch-Belgian Hemato-Oncology Co-operative Group HOVON; The Swiss Group for Clinical Cancer Research SAKK. Criteria for defining a complete remission in acute myeloid leukaemia revisited. An analysis of patients treated in HOVON-SAKK co-operative group studies. British Journal of Haematology, 128(2), 184-191. 2005 (also data of HOVON 4 and 4A);<br> 2. D.A. Breems, W.L. van Putten, P.C. Huijgens, G.J. Ossenkoppele, G.E. Verhoef, L.F. Verdonck, E. Vellenga, G.E. de Greef, E. Jacky, J. van der Lelie, M.A. Boogaerts and B. Löwenberg. Prognostic Index for Adult Patients With Acute Myeloid Leukemia in First Relapse. Journal of Clinical Oncology, 2005 Jan 4; [Epub ahead of print] (also data of HOVON 4 and 4A);<br> 3. B. Löwenberg, W. van Putten, M. Theobald, J. Gmür, L. Verdonck, P. Sonneveld, M. Fey, H. Schouten, G. de Greef, A. Ferrant, T. Kovacsovics, A. Gratwohl, S. Daenen, P. Huijgens, M. Boogaerts; Dutch-Belgian Hemato-Oncology Cooperative Group; Swiss Group for Clinical Cancer Research. Effect of priming with granulocyte colony-stimulating factor on the outcome of chemotherapy for acute myeloid leukemia. The New England Journal of Medicine, 349(8), 743-752. 2003; <br> 4. E. Vellenga, W.L.J. van Putten, M.A. Boogaerts, S.M.G.J. Daenen, G.E.G. Verhoef, A. Hagenbeek, A.R. Jonkhoff, P.C. Huijgens, L.F. Verdonck, J. van der Lelie, H.C. Schouten, J. Gmür, P. Wijermans, A. Gratwoh, U. Hess, M.F. Fey and B. Löwenberg. Peripheral blood stem cell transplantation as an alternative to autologous marrow transplantation in the treatment of acute myeloid leukemia. Bone Marrow Transplantation, 23, 1279-1282. 1999.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 1105
First randomization:
1. Patients with newly diagnosed de novo AML (including all cytological subtypes M0-M7);
First randomization:
1. Patients with a concurrent active malignancy, except stage I cervix carcinoma and basocellular carcinoma;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method CR rate.
- Secondary Outcome Measures
Name Time Method 1. Disease-free survival;<br /><br>2. Overall survival.