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
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|
- 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.
- 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.
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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)
Other Name: CYC
Other Name: PRED
Drug: vinblastine sulfate
Other Name: VBL
- Event-free survival [ Time Frame: 5 years ]Time from treatment start until relapse/progression, secondary malignancy or death
- 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
- Overall survival [ Time Frame: 5 years ]Time from treatment start until death
- Common Toxicity criteria toxicity Levels of therapy elements [ Time Frame: 5 years ]Evaluation of AEs, SAEs atc. according to CTC
- Complications of surgery [ Time Frame: 5 years ]Listing of surgical complications
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
|Giessen, Germany, D-35385|
|Principal Investigator:||Dieter Koerholz, MD||Universitaetsklinikum Giessen und Marburg|