Clinical trial NCT01088750: Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Official title: First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lymphoma
Keywords: childhood nodular lymphocyte predominant Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma
Lead sponsor: Martin-Luther-Universität Halle-Wittenberg
Sponsor class: OTHER
Collaborators: name: Deutsche Krebshilfe e.V., Bonn (Germany)
name: Euronet Worldwide
First posted: 2010-03-17
Enrollment: 225
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Event-free survival
timeFrame: 5 years
Secondary outcomes:
measure: Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II
timeFrame: 5 years
measure: Overall survival
timeFrame: 5 years
measure: Common Toxicity criteria toxicity Levels of therapy elements
timeFrame: 5 years
measure: Complications of surgery
timeFrame: 5 years
Other outcomes:
Locations:
city: Giessen
country: Germany
facility: Universitaetsklinikum Giessen-Marburg
Study officials:
affiliation: Universitaetsklinikum Giessen und Marburg
name: Dieter Koerholz, MD
role: PRINCIPAL_INVESTIGATOR
References: