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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001861-17-SE

Enrollment

270

Registered

2004-10-19

Start date

2004-12-12

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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.

Interventions

Product Name: prednisolon Pharmaceutical Form: Buccal tablet Pharmaceutical Form: Product Name: Adriamycin Pharmaceutical Form: Intravenous infusion Product Name: Methotrexat Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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. 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: death by any cause progressive disease non-response at day 33 late event EFS will be estimated using the Kaplan-Meier method Second end poin overall survial:defined as time of death by any cause (from randomisation) acute and long term toxicity non lymphoma related and early deaths	—

Measure

Time frame

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. 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: death by any cause progressive disease non-response at day 33 late event EFS will be estimated using the Kaplan-Meier method Second end poin overall survial:defined as time of death by any cause (from randomisation) acute and long term toxicity non lymphoma related and early deaths

—

Countries

Denmark, Italy, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026