Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Lymphoma
Type
Interventional
Phase
Phase 4
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Younger than 17 years
Gender
Both males and females

Description

OBJECTIVES: Primary Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone. Secondary Determine if this regimen results in a decrease i...

OBJECTIVES: Primary Determine the 5-year event-free survival of children or adolescents with stage IA or IIA nodular lymphocyte-predominant Hodgkin lymphoma treated with surgery alone or with cyclophosphamide, vinblastine, and prednisolone. Secondary Determine if this regimen results in a decrease in overall survival rates, in significant upstaging at relapse, or increased rates of histological transformation in these patients. OUTLINE: Group 1 (patients with stage IA disease only): Patients undergo surgical resection of the involved lymph nodes. Patients who achieve complete resection then enter follow-up (watch and wait); patients who do not achieve complete resection enters group 2 treatment. Group 2 (patients with stage IIA disease or incompletely resected stage IA disease): Patients receive cyclophosphamide, vinblastine, and prednisolone for 3 courses. Patients with good response enter follow-up (watch and wait). Patients without a good response are taken off protocol. After completion of study treatment, patients are followed-up periodically.

Tracking Information

NCT #
NCT01088750
Collaborators
  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • Euronet Worldwide
Investigators
Principal Investigator: Dieter Koerholz, MD Universitaetsklinikum Giessen und Marburg