Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

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.

Inclusion criteria

• nodular lymphocyte-predominant Hodgkin's lymphoma confirmed by reference pathology.
• initial stage IA/IIA (according to local staging) or relapse stage IA or IIA and residual tumour after relapse biopsy and no additional surgery planned in nLP patients relapsing after surgery alone
• patient aged under 18 years at time of diagnosis
• written informed consent of the patient and/or the patient's parents or guardian according to national laws

Exclusion criteria

• pre-treatment of Hodgkin's lymphoma differing from study protocol
• Any extra-nodal involvement
• Inability to fulfil protocol requirements for imaging (CT, MRI, FDG-PET) at staging and response assessment
• known hypersensitivity or contraindication to study drugs
• prior chemotherapy or radiotherapy
• Current or recent therapy (within 30 days prior to the start of trial treatment) with steroids
• Current or recent (within 30 days prior to the start of trial treatment) treatment with another investigational drug or participation in another investigational trial
• other (simultaneous) malignancies
• severe concomitant diseases (e.g. immune deficiency syndrome)
• known HIV positivity
• pregnancy and / or lactation
• females who are sexually active refusing to use effective contraception (oral contraception, intrauterine devices, barrier method of contraception in conjunction with spermicidal jelly or surgical sterile) (except for surgery only)