B-NHL BFM 04 - B-NHL BFM 04

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002345-39-SE

Enrollment

180

Registered

2005-11-29

Start date

2006-02-16

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

B-cell lymphoma or B-ALL in children up to 18 years of age

Interventions

Trade Name: Dexametasone Product Name: Dexacortal Product Code: 6292 Pharmaceutical Form: Tablet Trade Name: Metotrexat Product Name: Methotrexate Product Code: 14320 Pharmaceutical Form: Solution fo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with a mature B-cell non-Hodgkin lymphoma or B-ALL in Sweden fulfilling the following criteria: Verified diagnosis Written concent from patient/parent Under 19 years of age Start of treatment within the study period Treatment at a centre participating in the study No inclusion in other study protocols Pregnancy excluded in female patients 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: Previous malignancy Severe immunodeficiency HIV/AIDS Prevoius organ transplantation Concomittant disease interferring with treatment according to the protocol Treatment with cytostatic drugs, corticosteroids or irradtiation during the two weeks preceeding start of treament according to the study protocol

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective with the present study is to verify if the results from the earlier NHL BFM 95 study can be reproduced in a larger study group.;Primary end point(s): Event-free survival (EFS) defined as the time from start of treatment until death, whatever the cause of this, disease progression or late complication. EFS is calculated according to the Kaplan-Meier method;Secondary Objective: The seconary objectives are: 1) To verify if a shorter infusion time of methotrexate in the patients stratified to lower risk groups will result in lower incidence of mucositis in these patients, as shown in previous studies. 2) To verify if treatment in patients fulfitting high-risk criteria (initial CNS disease or primary mediastinal B-cell lymphoma) according to pecial treatment plan will result in better survival in these patients.	—

Measure

Time frame

Main Objective: The main objective with the present study is to verify if the results from the earlier NHL BFM 95 study can be reproduced in a larger study group.;Primary end point(s): Event-free survival (EFS) defined as the time from start of treatment until death, whatever the cause of this, disease progression or late complication. EFS is calculated according to the Kaplan-Meier method;Secondary Objective: The seconary objectives are: 1) To verify if a shorter infusion time of methotrexate in the patients stratified to lower risk groups will result in lower incidence of mucositis in these patients, as shown in previous studies. 2) To verify if treatment in patients fulfitting high-risk criteria (initial CNS disease or primary mediastinal B-cell lymphoma) according to pecial treatment plan will result in better survival in these patients.

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Countries

Sweden

Outcome results

None listed

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