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

Lymphoma Clinical Trial

— EuroNetLP1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01088750
• Other study ID #: CDR0000667369
• Secondary ID: 2007-004092-19
• Status: Completed
• Phase: Phase 4
• Start date: November 1, 2009
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 225
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hodgkin Disease
• Lymphoma

Intervention

Drug:
• cyclophosphamide

• prednisolone

• vinblastine sulfate

Other:
• watchful waiting

Procedure:
• therapeutic conventional surgery

Locations

Country	Name	City	State
Germany	Universitaetsklinikum Giessen-Marburg	Giessen

Sponsors (3)

Lead Sponsor	Collaborator
Christine Mauz-Körholz	Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event-free survival	Time from treatment start until relapse/progression, secondary malignancy or death	5 years
Secondary	Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II	Stage greater than IIA at relapse diagnosis	5 years
Secondary	Overall survival	Time from treatment start until death	5 years
Secondary	Common Toxicity criteria toxicity Levels of therapy elements	Evaluation of AEs, SAEs atc. according to CTC	5 years
Secondary	Complications of surgery	Listing of surgical complications	5 years

External Links

•   Clinical trial summary from the National Cancer Institute's PDQ® database