International study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
- Conditions
- standard risk ALK-positive anaplastic large cell lymphoma (ALCL)Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-501454-11-00
- Lead Sponsor
- GPOH gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 132
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, Informed 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method