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 randomised trial conducted in european countries and the five nordic countries 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 current nordic protocol for treatment of this disease is very similar with new Euro protocol the main difference being to administer dexamethason in the begining of the treatment and not -as to day - 3 months later.
- Registration Number
- EUCTR2004-001861-17-SE
- 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 under the age of 18 years with a T-/pre B-cells non-Hodgkins lymphomawill 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 Secondary Objective: ;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;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
Name Time Method