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

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ClinicalTrials.gov Identifier: NCT01088750
Recruitment Status : Active, not recruiting
First Posted : March 17, 2010
Last Update Posted : May 13, 2021
Sponsor:
Collaborators:
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Information provided by (Responsible Party):
Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 1, 2009
Estimated Primary Completion Date : October 31, 2023
Estimated Study Completion Date : October 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: CYC

Drug: prednisolone
Other Name: PRED

Drug: vinblastine sulfate
Other Name: VBL




Primary Outcome Measures :
  1. Event-free survival [ Time Frame: 5 years ]
    Time from treatment start until relapse/progression, secondary malignancy or death


Secondary Outcome Measures :
  1. 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

  2. Overall survival [ Time Frame: 5 years ]
    Time from treatment start until death

  3. Common Toxicity criteria toxicity Levels of therapy elements [ Time Frame: 5 years ]
    Evaluation of AEs, SAEs atc. according to CTC

  4. Complications of surgery [ Time Frame: 5 years ]
    Listing of surgical complications



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

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01088750


Locations
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Germany
Universitaetsklinikum Giessen-Marburg
Giessen, Germany, D-35385
Sponsors and Collaborators
Christine Mauz-Körholz
Deutsche Krebshilfe e.V., Bonn (Germany)
Euronet Worldwide
Investigators
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Principal Investigator: Dieter Koerholz, MD Universitaetsklinikum Giessen und Marburg
Additional Information:
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Responsible Party: Christine Mauz-Körholz, Prof. Dr. Christine Mauz-Körholz, Martin-Luther-Universität Halle-Wittenberg
ClinicalTrials.gov Identifier: NCT01088750    
Other Study ID Numbers: CDR0000667369
2007-004092-19 ( EudraCT Number )
First Posted: March 17, 2010    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Keywords provided by Christine Mauz-Körholz, 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:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Prednisolone
Cyclophosphamide
Vinblastine
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
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators