ALCL-VBL

Primary objectives

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

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.

• 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

• 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