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] - Cancer [C04]
- Registration Number
- EUCTR2017-002935-40-AT
- Lead Sponsor
- Gesellschaft für Pädiatrische Onkologie und Hämatologie (GPOH) gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 106
• 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
Are the trial subjects under 18? yes
Number of subjects for this age range: 106
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• 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
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