C84.6
Conditions
Interventions
Group 1: 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
Gesellschaft für pädiatrische Hämatologie und Onkologie (GPOH) gGmbH
Eligibility
Sex/Gender
All
Age
0 Years to 18 Years
Inclusion criteria
Inclusion criteria: •Stratification into the standard risk group (SR) by screening: o Newly diagnosed ALK-positive ALCL o Stage I not completely resected, or stage II or stage III o 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
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 o the obligatory initial intrathecal triple therapy with Methotrexate, Cytarabine and Prednisolone (or Hydrocortisone respectively) o 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: o hypersensitivity against VBL or other vinca-alkaloids o leukopenia, other than in the context of the ALCL o severe uncontrolled infection • Other medical, psychiatric, familial or social condition prohibiting treatment according to the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Objective and Endpoint • Objective: To show that it is possible to cure at least 75% of patients belonging to the SR group with Vinblastine-monotherapy for 24 months • Endpoint: 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 |
|---|---|
| Secondary Objectives and Endpoints • To describe overall survival and treatment related mortality of 24 months Vinblastine monotherapy. Overall survival is the time from diagnosis to death of any cause or last follow-up. • To identify clinical, pathological and biological factors predictive of progressive disease during / after VBL therapy. The time of progressive disease is the time from diagnosis to progressive disease or a competing event (death from any cause, secondary malignancy) or last follow-up. • To estimate the rate of SR patients requiring multi-agent chemotherapy • To describe the toxicity of Vinblastine given for 24 months rated with CTCAE v4.03. • To describe the response after 3 weeks (between day 17-22), 3 months and 6 months of treatment (including a possible pre-phase) assessed by appropriate imaging methods | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Netherlands, Norway, Spain, Sweden, Switzerland
Contacts
Public ContactWilhelm Wößmann
NHL-BFM Study Centre HamburgUniversity Medical Center Hamburg-EppendorfPediatric Hematology and Oncology
Outcome results
None listed