Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
NCT ID: NCT01088750
Last Updated: 2023-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
225 participants
INTERVENTIONAL
2009-11-01
2023-10-31
Brief Summary
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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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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surgery alone
watch and wait strategy after complete resection of localised (e.g. Stage IA) nodular lymphocyte-predominant HL
watchful waiting
therapeutic conventional surgery
CVP Chemotherapy
3 cycles of intensity-reduced, anthracycline-free chemotherapy (Cyclophosphamide, vinblastine and prednisone)
cyclophosphamide
prednisolone
vinblastine sulfate
Interventions
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cyclophosphamide
prednisolone
vinblastine sulfate
watchful waiting
therapeutic conventional surgery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
17 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
Euronet Worldwide
OTHER
Christine Mauz-Körholz
OTHER
Responsible Party
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Christine Mauz-Körholz
Prof. Dr. Christine Mauz-Körholz
Principal Investigators
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Dieter Koerholz, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaetsklinikum Giessen und Marburg
Locations
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Universitaetsklinikum Giessen-Marburg
Giessen, , Germany
Countries
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Related Links
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Clinical trial summary from the National Cancer Institute's PDQ® database
Other Identifiers
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2007-004092-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDR0000667369
Identifier Type: -
Identifier Source: org_study_id