Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma (EuroNetLP1)

Christine Mauz-Körholz

Status and phase: Completed; Phase 4

Conditions: Lymphoma

Treatments: Drug: prednisolone; Procedure: therapeutic conventional surgery; Drug: vinblastine sulfate; Drug: cyclophosphamide; Other: watchful waiting

Study type: Interventional

Funder types: Other

Identifiers

NCT01088750

CDR0000667369

2007-004092-19 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 225 patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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225 participants in 2 patient groups

surgery alone

Other group

Description:

watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL

Treatment:

Procedure: therapeutic conventional surgery

Other: watchful waiting

CVP Chemotherapy

Experimental group

Description:

3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)

Treatment:

Drug: cyclophosphamide

Drug: vinblastine sulfate

Drug: prednisolone