Surgery Alone, Surgery With Cyclophosphamide, Vinblastine, and Prednisolone (CVP), or CVP Alone in Treating Young Patients With Stage IA or Stage IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Martin-Luther-Universität Halle-Wittenberg
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier:
NCT01088750
First received: March 16, 2010
Last updated: November 17, 2015
Last verified: November 2015
  Purpose

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 Intervention Phase
Lymphoma
Drug: cyclophosphamide
Drug: prednisolone
Drug: vinblastine sulfate
Other: watchful waiting
Procedure: therapeutic conventional surgery
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents

Resource links provided by NLM:


Further study details as provided by Martin-Luther-Universität Halle-Wittenberg:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Toxicity [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
  • Complications of surgery [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: November 2009
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
Drug: cyclophosphamide
Other Name: CYC
Drug: prednisolone Drug: vinblastine sulfate
Other Name: VBL

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

Ages Eligible for Study:   up to 17 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma

    • Stage IA or IIA disease

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior therapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01088750

Contacts
Contact: Dieter Koerholz, MD dieter.koerholz@paediat.med.uni-giessen.de
Contact: Christine Mauz-Koerholz, MD christine.mauz-koerholz@paediat.med.uni-giessen.de

Locations
Germany
Universitaetsklinikum Giessen-Marburg Recruiting
Giessen, Germany, D-35385
Contact: Contact Person    0049-641-985- ext 57921    dieter.koerholz@paediat.med.uni-giessen.de   
Contact: Christine Mauz-Koerholz, MD       christine.mauz-koerholz@paediat.med.uni-giessen.de   
Sponsors and Collaborators
Christine Mauz-Körholz
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Investigators
Principal Investigator: Dieter Koerholz, MD Universitaetsklinikum Giessen und Marburg
  More Information

Additional Information:
Responsible Party: Christine Mauz-Körholz, Prof. Dr. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01088750     History of Changes
Other Study ID Numbers: CDR0000667369  EURONET-PHL-LP1  EUDRACT-2007-004092-19  EU-21011 
Study First Received: March 16, 2010
Last Updated: November 17, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Martin-Luther-Universität Halle-Wittenberg:
childhood nodular lymphocyte predominant Hodgkin lymphoma
stage I childhood Hodgkin lymphoma
stage II childhood Hodgkin lymphoma

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Prednisolone
Methylprednisolone Hemisuccinate
Vinblastine
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 23, 2016