Ignite Creation Date:
2024-05-05 @ 10:21 PM
Last Modification Date:
2024-10-26 @ 10:17 AM
Study NCT ID:
NCT01088750
Status:
COMPLETED
Last Update Posted:
2023-12-13
First Post:
2010-03-16
Brief Title:
Surgery Alone or With CYC VBL and PRED or CVP Alone in Stage IA or IIA Nodular Lymphocyte-Predominant Hodgkin Lymphoma
Sponsor:
Christine Mauz-Körholz
Organization:
Martin-Luther-Universität Halle-Wittenberg
Study Overview
Official Title:
First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkins Lymphoma in Children and Adolescents
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EuroNetLP1
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2007-004092-19 | EUDRACT_NUMBER | None | None |