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

December 6, 2023 updated by: Christine Mauz-Körholz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

225

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Giessen, Germany, D-35385
        • Universitaetsklinikum Giessen-Marburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: surgery alone
watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
Procedure: therapeutic conventional surgery
Other: watchful waiting
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free survival
Time Frame: 5 years
Time from treatment start until relapse/progression, secondary malignancy or death
5 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christine Mauz-Körholz

Collaborators

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

Investigators

  • Principal Investigator: Dieter Koerholz, MD, Universitaetsklinikum Giessen und Marburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

October 31, 2023

Study Completion (Actual)

October 31, 2023

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 16, 2010

First Posted (Estimated)

March 17, 2010

Study Record Updates

Last Update Posted (Estimated)

December 13, 2023

Last Update Submitted That Met QC Criteria

December 6, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000667369
  • 2007-004092-19 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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