RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, vinblastine, and
prednisolone, work in different ways to stop the growth of cancer cells, either by
killing the cells or by stopping them from dividing. Surgery to remove involved lymph
nodes may be an effective treatment for young patients with nodular
lymphocyte-predominant Hodgkin lymphoma.
PURPOSE: This phase IV trial is continuing to study the side effects of giving surgery
alone or giving surgery with cyclophosphamide, vinblastine, and prednisolone compared
with giving cyclophosphamide, vinblastine, and prednisolone alone in treating young
patients with stage IA or stage IIA nodular lymphocyte-predominant Hodgkin lymphoma.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT01088750.
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.
Lead OrganizationChristine Mauz-Körholz
