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Trial record 1 of 1 for:    NCT01088750
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01088750
Recruitment Status : Active, not recruiting
First Posted : March 17, 2010
Last Update Posted : March 26, 2020
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg

Tracking Information
First Submitted Date  ICMJE March 16, 2010
First Posted Date  ICMJE March 17, 2010
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE November 1, 2009
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2015)
Event-free survival [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
Event-free survival
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 24, 2020)
  • Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II [ Time Frame: 5 years ]
  • Overall survival [ Time Frame: 5 years ]
  • Common Toxicity criteria toxicity Levels of therapy elements [ Time Frame: 5 years ]
  • Complications of surgery [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 16, 2010)
  • Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II
  • Overall survival
  • Toxicity
  • Complications of surgery
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents
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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Lymphoma
Intervention  ICMJE
  • Drug: cyclophosphamide
    Other Name: CYC
  • Drug: prednisolone
  • Drug: vinblastine sulfate
    Other Name: VBL
  • Other: watchful waiting
  • Procedure: therapeutic conventional surgery
Study Arms  ICMJE
  • surgery alone
    watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
    Interventions:
    • Other: watchful waiting
    • Procedure: therapeutic conventional surgery
  • Experimental: CVP
    3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
    Interventions:
    • Drug: cyclophosphamide
    • Drug: prednisolone
    • Drug: vinblastine sulfate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2010)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 31, 2023
Estimated Primary Completion Date October 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma

    • Stage IA or IIA disease

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • No prior therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01088750
Other Study ID Numbers  ICMJE CDR0000667369
EURONET-PHL-LP1
EUDRACT-2007-004092-19
EU-21011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
Study Sponsor  ICMJE Christine Mauz-Körholz
Collaborators  ICMJE
  • Deutsche Krebshilfe e.V., Bonn (Germany)
  • Euronet Worldwide
Investigators  ICMJE
Principal Investigator: Dieter Koerholz, MD Universitaetsklinikum Giessen und Marburg
PRS Account Martin-Luther-Universität Halle-Wittenberg
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP