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Multizentre observational study for treatment of children and adolescents with mature B-cell Non-Hodgkin-Lymphoma/leukemia

Multizentre observational study for treatment of children and adolescents with mature B-cell Non-Hodgkin-Lymphoma/leukemia - B-NHL BFM 04

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00009436
Enrollment
660
Registered
2015-10-08
Start date
2004-03-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

C85

Interventions

Group 1: Stratification of treatment intensity into 4 risk groups R1: Stage I and II, completely resected, 2 courses A, B R2: Stage I and II, uncompletely resected, Stage III, LDH=100U/L, or/and CNS

Sponsors

Justus-Liebig-Universität Gießen, Universitätsklinikum Gießen, Abteilung Pädiatrische Hämatologie und Onkologie
Lead Sponsor

Eligibility

Sex/Gender
All
Age
0 Years to 18 Years

Inclusion criteria

Inclusion criteria: newly diagnosed mature B-NHL or B-ALL informed consent of patient/guardian start of therapy within recruting period of study treatment in a participating centre of study no participation in a concurrend clinical trial no evidence of pregnancy effective contraception

Exclusion criteria

Exclusion criteria: previous malignancy severe immunondeficiency HIV/AIDS previous organ transplantation preexisting disease prohibiting chemotherapy as per protocol significant cytoreductive pre-treatment

Design outcomes

Primary

MeasureTime frame
probability of event-free survival from diagnosis until one year after diagnosis. Events are: recurrence, secondary malignancies or death from any cause

Secondary

MeasureTime frame
toxicity according to NCI criteria particularly of intensified intrathecal therapy in CNS-positive patients during chemotherapy until one month after chemotherapy

Countries

Austria, Czechia, Germany, Switzerland

Contacts

Public ContactAlfred Reiter

Justus-Liebig-Universität Gießen, Abt. Pädiatrische Hämatologie und Onkologie

alfred.reiter@paediat.med.uni-giessen.de0641-98543626

Outcome results

None listed

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