Author:  Julia Dobke, Last modification: 2022/11/30

ALCL-VBL International cooperative study for children and adolescents with standard risk anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
Disease Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma
Type International prospective open-label non-randomized study
Problem / Objectives

Primary objectives

To show that it is possible to eure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months.

Therapy / Study arms

Vinblastine: 6 mg/m2 (max 10 mg) intravenous (i.v.) for a total treatment duration of 24 months, weekly for 18 months and bi-weekly for the final 6 months.

Inclusion Criteria
  • Stratification into the standard risk group (SR) by screening: Newly diagnosed ALK-positive ALCL: Stage I not completely resected, or stage II or stage III, MDD negative, Age < 18 years
  • lnformed consent of the parents/legal guardians (and assent of the competent child) for study participation and data collection, storage and handling given before study entry
  • Participation in national / study group's reference pathology
  • Follow-up for at least 3 years after enrolment is expected
  • Application of a highly effective contraceptive method (Pearl index <1) in sexually active patients
  • Application of one intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) before start of the protocol treatment
Exclusion Criteria
  • Progressive disease during a possible clinically indicated pre-phase treatment before inclusion in the study
  • Steroids for more than 2 days or chemotherapy pre-treatment before taking the screening sample for MDD
  • Chemotherapy pre-treatment before start of the study treatment except for: the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively), a possible clinically indicated pre-phase including up to 5 days of steroids combined with up to 3 doses of Vinblastine (and up to 2 doses of Cyclophosphamide)
  • Pregnancy or lactation period
  • Contraindications for the treatment with Vinblastine: hypersensitivity against VBL or other vinca-alkaloids, leukopenia, other than in the context of the ALCL, severe uncontrolled infection
  • Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol
Recruitment 106 patients in 5 years
Status 01.04.2022-30.03.2027
EudraCT 2017-002935-40
Entry Study Register
Principal Investigator Prof. Dr. med. W. Wößmann

Principal investigator

Prof. Dr. med. Wilhelm Wößmann Universitätsklinikum Hamburg-Eppendorf Klinik für Pädiatrische Hämatologie und Onkologie Martinistr. 52 20246 Hamburg Telefon +49 (40) 7410 20561 Fax +49 (40) 7410 40488

Trial documentation

Dr. med. Jan Förster Universitätsklinikum Hamburg Gebäude N21 Martinistr. 52 02426 Hamburg Telefon +49 40 7410-53716

Participants EICNHL-group: AIEOP (ltaly), BFM (Austria, Germany, Switzerland, Czech Republic), UK-CCLG, DCOG (Netherlands), BSPHO (Belgium), NOPHO (Sweden, Norway, Finland, Denmark, Island), Poland, SFCE (France), SEHOP (Spain), Hungary, potentially HKPHSOG (Hong Kong), Japan
Weitere Informationen Sponsor: GPOH gGmbH