ALCL 99

Author:  J. Dobke, erstellt am 2005/02/12, Last modification:  2012/06/22

ALCL 99 ALCL 99: International Protocol for the Treatment of Childhood Anaplastic Large Cell Lymphoma
Disease Anaplastic Large Cell Lymphoma, CD30-positive Lymphoproliferations of the skin, ALK-positive B-cell Non-Hodgkin-Lymphoma
Type Therapy optimising trial, international multicenter Therapy Trial of the EICNHL-Group (European Intergroup Cooperation on Childhood Non-Hodgkin-Lymphoma)
Problem / Objectives

Main objectives of the trial: to improve eventfree and overall survival
Second objective: to verify the criteria for stratification

Therapy / Study arms

Classification of therapeutic groups and treatment plan

The very rare patients with isolated skin disease (completely resected or not) will not receive any chemotherapy. This requires a very complete evaluation. Such patients should be discussed with the study coordinator to confirm the very cautious « wait and see » decision.

Low risk group (LR): Stage I disease completely resected

All patients receive the prephase and 3 blocks Chemotherapy (AM, BM AM)

Group SR (Standard risk group)

The randomisation has been closed since 22/05/2006. All patients receive the prephase and treatment arm 3 with MTX 3g/m² and 6 blocks of Chemotherapy (3 x AM and 3 x BM alternating).

Group HR (High risk group)

Randomisation has been closed since 22nd of May 2006. All patients in trial should be treated according to arm 3 with 3g MTX/m² without intrathecal injections and without Vinblastine.

Inclusion Criteria
  • ALCL diagnosed by local pathologist
  • Slides available for national pathology review for all cases. If the local pathologist refuses to send slides (either cytological or histological) for central review, the patient is not eligible except in the situation where the presence of t(2;5) is proven.
  • No previous treatment (except for corticosteroids which should not have been given for more than 8 days).
  • Age < 22 years.
Recruitment 96
Status 30.04.2004
Entry Study Register ClinicalTrials.gov: NCT00006455
Principal Investigator Prof. Dr. med. Alfred Reiter
E-Mail nhl.studie@paediat.med.uni-giessen.de
Contact

Investigator

Prof. Dr. med. Alfred Reiter Universitätsklinikum Gießen und Marburg GmbH Zentrum f. Kinderheilkunde, Päd. Hämatologie u. Onkologie Feulgenstraße 12 35392 Gießen Telefon +49 (641) 985 43420 Fax +49 (641) 985 43429 alfred.reiter@paediat.med.uni-giessen.de

Coordination

Prof. Dr. Dr. Birgit Burkhardt Universitätsklinikum Münster Klinik und Poliklinik für Kinder- und Jugendmedizin, Pädiatrische Hämatologie und Onkologie Albert-Schweitzer-Campus 1 48149 Münster Telefon +49 (251) 83 55696 Fax +49 (251) 83 43405 birgit.burkhardt@ukmuenster.de

Documentation

Participants AIEOP/Italy, BFM Austria, Germany, Switzerland, DCLSG/The Netherlands, EORTC/France, Belgium, National Instituto di Tumori, Milan/Italy, NOPHO/Norway, Sweden, Finland, Denmark, Island, Poland, SFOP/France, Spain, UKCCSG/UK