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

Sponsor

Christine Mauz-Körholz (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01088750

Collaborator

Deutsche Krebshilfe e.V., Bonn (Germany) (Other), Euronet Worldwide (Other)

200

Enrollment

Location

Arms

168

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma	Drug: cyclophosphamide Drug: prednisolone Drug: vinblastine sulfate Other: watchful waiting Procedure: therapeutic conventional surgery	Phase 4

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents

Actual Study Start Date :

Nov 1, 2009

Anticipated Primary Completion Date :

Oct 31, 2023

Anticipated Study Completion Date :

Oct 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: surgery alone watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL	Other: watchful waiting Procedure: therapeutic conventional surgery
Experimental: CVP Chemotherapy 3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)	Drug: cyclophosphamide Other Names: CYC Drug: prednisolone Other Names: PRED Drug: vinblastine sulfate Other Names: VBL

Arm

Intervention/Treatment

Other: surgery alone

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

Other: watchful waiting

Procedure: therapeutic conventional surgery

Experimental: CVP Chemotherapy

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

Drug: cyclophosphamide

Other Names:

CYC

Drug: prednisolone

Other Names:

PRED

Drug: vinblastine sulfate

Other Names:

VBL

Outcome Measures

Primary Outcome Measures

Event-free survival [5 years]
Time from treatment start until relapse/progression, secondary malignancy or death

Secondary Outcome Measures

Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II [5 years]
Stage greater than IIA at relapse diagnosis
Overall survival [5 years]
Time from treatment start until death
Common Toxicity criteria toxicity Levels of therapy elements [5 years]
Evaluation of AEs, SAEs atc. according to CTC
Complications of surgery [5 years]
Listing of surgical complications

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)