EURO-LB-02. Treatment Protocol for Lymphoblastic Lymphoma of the European Inter-group Co-operation on Childhood Non-Hodgkin-Lymphoma (EICNHL). - EURO-LB 02

Conditions: Multicenter European randomised trial on children up to the age of 18 years newly diagnosed with T-cell and and pre -B lymphoblastic lymphoma (T-LBL pre-B-LBL ). The protocol is similar to the current Nordic and other European protocols. The main difference is whether to administer dexamethasone or prednisolone during the first weeks of induction therapy and whether the total duration of therapy can be shortened from 24 to 18 months for T-cell lymphoma.

Registration Number: EUCTR2004-001861-17-DK

Lead Sponsor: OPHO-NHL GRUPP

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

All newly diagnosed patients at the involved centers under the age of 18 years with a T-/pre B-cells non-Hodgkins lymphoma can be included.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

HIV infection or AIDS
previous organ transplantation
previous malignancy
pre-existing disease prohibiting chemotherapy as per se instructions of the Protocol
previous chemotherapy or radiotherapy
previous systemic corticosteroid treatment for more than 8 days withon two months before beginning the Euro protocol

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The first aim is to test the impact of replacing Prednisolone by Dexamethasone during induction treatment on the improvment of the event free survival of patients newly diagnosed with T- LBL. <br>The second aim is to test whether for patients with T-LBL the standard maintenance therapy of 24 months total terapy duration can safely be reduced to 18 months;Secondary Objective: ;Primary end point(s): The conditional event free survival (EFS), defined as minimum time from the date of randomisation to:<br>death by any cause<br>progressive disease<br>non-response at day 33<br>late event<br>EFS will be estimated using the Kaplan-Meier method<br>Second end poin overall survial:defined as time of death by any cause (from randomisation)<br>acute and long term toxicity<br>non lymphoma related and early deaths

Secondary Outcome Measures