Know Cancer

or
forgot password

First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents


Phase 4
N/A
17 Years
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

First International Inter-Group Study for Nodular Lymphocyte-Predominant Hodgkin's Lymphoma in Children and Adolescents


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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of nodular lymphocyte-predominant Hodgkin lymphoma

- Stage IA or IIA disease

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- No prior therapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Event-free survival

Safety Issue:

No

Principal Investigator

Dieter Koerholz, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Martin-Luther-Universit├Ąt Halle-Wittenberg

Authority:

Unspecified

Study ID:

CDR0000667369

NCT ID:

NCT01088750

Start Date:

November 2009

Completion Date:

Related Keywords:

  • Lymphoma
  • childhood nodular lymphocyte predominant Hodgkin lymphoma
  • stage I childhood Hodgkin lymphoma
  • stage II childhood Hodgkin lymphoma
  • Hodgkin Disease
  • Lymphoma

Name

Location