ALCL 99

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

Title 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
EudraCT
Entry Study Register ClinicalTrials.gov: NCT00006455
Principal Investigator Prof. Dr. med. Alfred Reiter
E-Mail mailto: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

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

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
Documents
Link(s) Studienliteratur Non-Hodgkin-Lymphome
Nachsorgeplan Großzellig anaplastische Lymphome