ALCL-Relapse

Prymary objectives

• to improve the probability of event free survival in children and adolescents with early progression of ALCL or/and a relapse of ALCL with CD3 positive immunophenotype
• to test whether in patients with relapse of CD3 negative ALCL occurring after the intensive phase of frontline treatment BEAM conditioning regimen (without TBI) for autologous stem cell transplantation is an effective treatment
• to test the impact of Vinblastine in patients with late relapse of an CD3 negative ALCL

Die Zwischenanalyse zu Anfang 2012 hat ergeben, dass die autologe Transplantation keine Alternative zur allogenen SZT darstellt. Die hieraus folgenden Therapieänderungen sind unter Therapie/Studienarme aufgeführt.

Stratification

• Timepoint of the relapse
• Immunophenotype of the ALCL
• Availability of MSD or 10/10 MUD Sc-donor
• Vinblastine administration during frontline therapy

Classification of therapeutic groups

entsprechend des Amendements vom 06/2012.

• Arm 1: Early progression
• Arm 2: Relapse and CD3 positive lymphoma cells: Arm 2a: a matched sibling donor or a 10/10 matched non-sibling donor is available; Arm 2b: no matched sibling donor or a 10/10 matched non-sibling donor available
• Arm 3: Relapse and CD3 negative immunophenotype
• Arm 4: Late relapse and CD3 negative immunophenotype

Therapie

entsprechend des Amendements vom 06/2012:

Arm A: 2 Blöcke Salvage-Chemotherapie mit anschließender allogener Stammzelltransplantation (alle Spender)
Arm 2a: 2-3 Blöcke Salvage-Chemotherapie mit anschließender allogener Stamzelltransplantation (MSD oder >=9/10 MUD)
Arm 2b new: 2-3 Blöcke Salvage-Chemotherapie, gefolgt von Vinblastingaben bis zu einer Gesamttherapiedauer von 24 Monaten
Arm 3 new: 24 Monate Vinblastin, im Falle eines Rezidives allogene Stammzelltransplantation

• progression or relapse of ALCL
• age < 22 years
• slides of relapsed lymphoma available for national pathological and/or cytomorphology review
• signed informed consent of patient/guardians for participation in the study ALCL-Relapse
• no evidence of pregnancy or lactation period; assured contraception
• no participation in another clinical study, recruitment in study ALCLRelapse during run time of the study

Patients who fulfil the eligibility criteria of the study but who meet one of the following criteria are not evaluable for trial’s results. Nevertheless, they should be registered and documented in the study.

• 2nd, or subsequent relapse of ALCL
• significant pre-treatment for 1st relapse
• no adequate hepatic, renal and cardiac function
• HIV infection or AIDS, severe immunodeficiency
• previous organ transplantation
• previous malignancy prior to the anaplastic large cell lymphoma
• pre-existing disease prohibiting treatment as per instruction of protocol