ALL-REZ BFM 2002


The project ALL-REZ BFM 02 Pilot is a pilotphase of the protocol ALL-REZ BFM 2002. The protocol ALL-REZ BFM 2002 is a prospective, controlled, randomized, multi-center study to optimize treatment of children with relapsed ALL with about 100 participating centers from Germany, Austria and Switzerland. The design is based on experience from 5 preceding trials of the ALL-REZ BFM Study Group since 1983. Central elements are short intensive multi-drug chemotherapy courses, followed by cranial irradiation and maintenance therapy. A series of risk factors allow to define patients with an acceptable prognosis after chemotherapy and those, who need further intensification by stem-cell transplantation (SCT). However, the indication of SCT in intermediate risk patients remains unclear. Main aim of the study is a randomized comparison of a less intensive continuous consolidation therapy (Prot-II-IDA) with the former short intensive multi-drug courses. Endpoints are reduction of minimal residual disease (MRD), event-free- and overall survival as well as toxicity of both strategies. Secondary aims are to improve prognosis of intermediate risk patients by allocation to SCT according to the MRD-level after 2 induction courses and a series of concomitant experimental studies.
Head of Project:

Univ. Prof. Dr. Guenter Henze
Dr.med. von Arend Stackelberg
Charité - Universitätsmedizin Berlin
Department of Pediatric Oncology and Hematology CVK
Tel. 450-566031
Fax 450-566906
guenter.henze@charite.de
Begin/End of Project:

04/2007 - 11/2010
Funded by:

Stiftung Deutsche KinderKrebshilfe
Online-Information:

www.charite.de.paedonko/e138/
Publications:

1. Chessells, J.M. (1998). Relapsed lymphoblastic leukaemia in children: A continuing challenge. Br J Haematol, 102, 423-38. 2. Eckert, C., Biondi, A., Seeger, K., Cazzaniga, G., Hartmann, R., Beyermann, B., Pogodda, M., Proba, J. & Henze, G. (2001). Prognostic value of minimal residual disease in relapsed childhood acute lymphoblastic leukaemia. Lancet, 358, 1239-41. 3. Gaynon, P.S., Qu, R.P., Chappell, R.J., Willoughby, M.L., Tubergen, D.G., Steinherz, P.G. & Trigg, M.E. (1998). Survival after relapse in childhood acute lymphoblastic leukemia: Impact of site and time to first relapse - the Children's Cancer Group Experience. Cancer, 82, 1387-95. 4. Henze, G. (1997). Chemotherapy for relapsed childhood acute lymphoblastic leukemia. Int J Pediatr Hematol Oncol, 5, 199-213. 5. Seeger, K., Stackelberg, A.V., Taube, T., Buchwald, D., Korner, G., Suttorp, M., Dorffel, W., Tausch, W. & Henze, G. (2001). Relapse of TEL-AML1--positive acute lymphoblastic leukemia in childhood: a matched-pair analysis. J Clin Oncol, 19, 3188-93.