Treatment Protocol for T-Cell and B-Precursor Cell 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

EUCTR2007-005396-34-GB

Enrollment

173

Registered

2010-08-31

Start date

2004-09-22

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

lymphoblastic lymphoma MedDRA version: 9.1 Level: LLT Classification code 10065923 Term: Lymphoblastic lymphoma

Interventions

Trade Name: dexamethasone Product Name: dexamethasone Pharmaceutical Form: Tablet INN or Proposed INN: DEXAMETHASONE CAS Number: 50022 Concentration unit: mg milligram(s) Concentration type: range Con

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? lymphoblastic lymphoma diagnosed either by histomorphological or cytomorphological characterisation ? age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: ? HIV infection or AIDS ? severe immunodeficiency ? previous organ transplantation ? previous malignancy ? pre-existing disease prohibiting chemotherapy as per instructions of the Protocol ? previous chemotherapy or radiotherapy ? previous systemic corticosteroid treatment for more than 8 days within two months before the beginning of therapy according to this Protocol EURO-LB 02

Design outcomes

Primary

Measure	Time frame
Main Objective: • The first aim of the study is to test the impact of replacing Prednisolone by Dexamethasone during Induction treatment (Protocol I) on the event free survival of patients with newly diagnosed T-LBL. • The second question is to test whether for patients with T-LBL the standard maintenance therapy of 24 months total therapy duration can safely be reduced to 18 months (calculated from the first day of treatment). ;Secondary Objective: • To test if the treatment results of study NHL-BFM 90 can be reproduced in an international study including most European study groups. The omission of prophylactic cranial irradiation for patients with advanced stage disease in this current study EURO-LB 02 has to be considered in this regard. • To evaluate prognostic factors highly predictive for treatment failure. • To study the epidemiology and biology of the disease. ;Primary end point(s): The main end point is the conditional event free survival (EFSc), defined as minimum time from the date of randomisation to: - death by any cause - progressive disease - non-response at day 33: > 5% blasts in BM and/or blasts in CSF or/and <35% regression of primary tumour. In case of non-response, the date of event will be considered the date of the beginning of treatment) - second malignancy - late event (malignancy more than 3 years after diagnosis of T-LBL; no differentiation between progression and second malignancy possible) EFSc will be estimated using the Kaplan-Meier method.	—

Measure

Time frame

Main Objective: • The first aim of the study is to test the impact of replacing Prednisolone by Dexamethasone during Induction treatment (Protocol I) on the event free survival of patients with newly diagnosed T-LBL. • The second question is to test whether for patients with T-LBL the standard maintenance therapy of 24 months total therapy duration can safely be reduced to 18 months (calculated from the first day of treatment). ;Secondary Objective: • To test if the treatment results of study NHL-BFM 90 can be reproduced in an international study including most European study groups. The omission of prophylactic cranial irradiation for patients with advanced stage disease in this current study EURO-LB 02 has to be considered in this regard. • To evaluate prognostic factors highly predictive for treatment failure. • To study the epidemiology and biology of the disease. ;Primary end point(s): The main end point is the conditional event free survival (EFSc), defined as minimum time from the date of randomisation to: - death by any cause - progressive disease - non-response at day 33: > 5% blasts in BM and/or blasts in CSF or/and <35% regression of primary tumour. In case of non-response, the date of event will be considered the date of the beginning of treatment) - second malignancy - late event (malignancy more than 3 years after diagnosis of T-LBL; no differentiation between progression and second malignancy possible) EFSc will be estimated using the Kaplan-Meier method.

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Countries

United Kingdom

Outcome results

None listed

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