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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)

Primary Purpose

Lymphoma

Status
Active
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
cyclophosphamide
prednisolone
vinblastine sulfate
watchful waiting
therapeutic conventional surgery
Sponsored by
Christine Mauz-Körholz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring childhood nodular lymphocyte predominant Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Universitaetsklinikum Giessen-Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

surgery alone

CVP Chemotherapy

Arm Description

watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL

3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)

Outcomes

Primary Outcome Measures

Event-free survival
Time from treatment start until relapse/progression, secondary malignancy or death

Secondary Outcome Measures

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
Overall survival
Time from treatment start until death
Common Toxicity criteria toxicity Levels of therapy elements
Evaluation of AEs, SAEs atc. according to CTC
Complications of surgery
Listing of surgical complications

Full Information

First Posted
March 16, 2010
Last Updated
May 10, 2021
Sponsor
Christine Mauz-Körholz
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide
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1. Study Identification

Unique Protocol Identification Number
NCT01088750
Brief Title
Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Acronym
EuroNetLP1
Official Title
First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 1, 2009 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christine Mauz-Körholz
Collaborators
Deutsche Krebshilfe e.V., Bonn (Germany), Euronet Worldwide

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
childhood nodular lymphocyte predominant Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II childhood Hodgkin lymphoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
surgery alone
Arm Type
Other
Arm Description
watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
Arm Title
CVP Chemotherapy
Arm Type
Experimental
Arm Description
3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
CYC
Intervention Type
Drug
Intervention Name(s)
prednisolone
Other Intervention Name(s)
PRED
Intervention Type
Drug
Intervention Name(s)
vinblastine sulfate
Other Intervention Name(s)
VBL
Intervention Type
Other
Intervention Name(s)
watchful waiting
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Primary Outcome Measure Information:
Title
Event-free survival
Description
Time from treatment start until relapse/progression, secondary malignancy or death
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Significant upstaging at relapse defined as development of B-symptoms, extranodal disease, or relapse higher than stage II
Description
Stage greater than IIA at relapse diagnosis
Time Frame
5 years
Title
Overall survival
Description
Time from treatment start until death
Time Frame
5 years
Title
Common Toxicity criteria toxicity Levels of therapy elements
Description
Evaluation of AEs, SAEs atc. according to CTC
Time Frame
5 years
Title
Complications of surgery
Description
Listing of surgical complications
Time Frame
5 years

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dieter Koerholz, MD
Organizational Affiliation
Universitaetsklinikum Giessen und Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinikum Giessen-Marburg
City
Giessen
ZIP/Postal Code
D-35385
Country
Germany

12. IPD Sharing Statement

Links:
URL
https://www.cancer.gov/about-cancer/treatment/clinical-trials/search/v?a=8&id=NCI-2014-02026&loc=0&rl=2&st=C7258&t=C9357
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

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

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