Anaplastic large-cell lymphoma (ALCL) lymphnode cancer
Conditions
Interventions
Vinblastine monotherapy: 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
Sponsors
German Pediatric Oncology Group (GPOH) gGmbH
Eligibility
Age
No minimum to 17 Years
Inclusion criteria
Inclusion criteria: * Stratification into the standard risk group (SR): -Newly diagnosed ALK-positive ALCL -Stage I not completely resected, or stage II or stage III -MDD negative * Age
Exclusion criteria
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 (or 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Probability of event-free-survival (pEFS) at 3 years, with EFS defined as the time of diagnosis to the first event (progressive disease, nonresponse, secondary malignancy or death due to any cause) or last follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival - Treatment related mortality - Time from diagnosis to progressive disease /event - Toxicity - Response | — |
Countries
Netherlands
Outcome results
None listed