International cooperative prospective study for children and adolescents with standard risk ALK-positive anaplastic large cell lymphoma (ALCL) estimating the efficacy of Vinblastine
- Conditions
- C84.6Anaplastic large cell lymphoma, ALK-positive
- Registration Number
- DRKS00023541
- Lead Sponsor
- Gesellschaft für pädiatrische Hämatologie und Onkologie (GPOH) gGmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- 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
• 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
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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Objective and Endpoint<br>• 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<br>• Endpoint: Probability of event-free-survival (pEFS) at 3 years, with EFS defined as the time of diagnosis to the first event (progressive disease,<br>nonresponse, secondary malignancy or death due to any cause) or last follow-up.
- Secondary Outcome Measures
Name Time Method Secondary Objectives and Endpoints<br>• 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.<br>• 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.<br>• To estimate the rate of SR patients requiring multi-agent chemotherapy<br>• 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