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Treatment Protocol of the NHL-BFM and the NOPHO Study Groups for Mature Aggressive B-cell Lymphoma and Leukemia in Children and Adolescents

Study acronym: B-NHL 2013
StatusActive, Not Recruiting
PhasePhase 3
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv17
  2. Primary and study completion dates: Aug 2024 to Jun 2027
    • Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 92 to 88
    v16
  3. Re-verified, no change to tracked fieldsv15
  4. Site details revised at 8 of 92 sitesv14
  5. Eligibility criteria expanded, about 29 wordsv13
Show 11 earlier versionsHide 11 earlier versions
  1. Study sites: 91 to 92v12
  2. Study sites: 90 to 91v11
  3. Re-verified, no change to tracked fieldsv10
  4. Site details revised at 7 of 90 sitesv9
  5. Site details revised at 3 of 90 sitesv8
  6. Study sites: 53 to 90v7
  7. Site details revised at 2 of 53 sitesv6
  8. Site details revised at 8 of 53 sitesv5
  9. Site contacts updated at 53 of 53 sitesv4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Jul 2024 to Aug 2024
    • Start date changed from estimate of Jul 2017 to Aug 3, 2017
    • Site details revised at 53 of 53 sites
    v3
  11. Study sites: 0 to 53v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The trial B-NHL 2013 is a collaborative prospective, multi-national, multi-center, randomized trial with participating centers of the NHL-BFM group (Austria, Switzerland, Czech Republic, Germany) and the Scandinavian NOPHO group (Denmark, Finland, Norway, Sweden). The aim of the trial is to evaluate the role of rituximab in the treatment of mature aggressive B-cell Non-Hodgkin lymphoma and leukemia (B-NHL and B-AL) in children and adolescents. The following primary study questions are going to be analyzed: * the effectiveness (event-free survival) in pediatric patients with very limited mature B-NHL (R1 and R2 stage I and II) of substituting anthracyclines by the rituximab window without compromising survival rates. * the effectiveness (event-free survival) in pediatric patients with limited mature B-NHL (R2 stage III) randomly assigned to receive the rituximab window plus standard chemotherapy or standard chemotherapy without the rituximab window. * the effectiveness (event-free survival) and the immune reconstitution (recovery of CD19+ B-cells, IR) in pediatric patients with advanced mature B-NHL/B-AL (R3 and R4 incl. R4 CNS+) treated with BFM-type chemotherapy and randomly assigned schedules of one versus seven doses rituximab. Secondary study questions will address * additional parameters for immune reconstitution, lymphocyte subpopulations, immunoglobulin levels, vaccination titers and infection rates * kinetics of immune reconstitution after treatment * adverse event and severe adverse event profile * inter-individual variability of rituximab response * role of different mechanisms of action of rituximab in advanced B-NHL/B-AL
Trial Details
NCT Number NCT03206671
Lead Sponsor University Hospital Muenster
Collaborators: Deutsche Krebshilfe e.V., Bonn (Germany)
Conditions
(from sponsor)		 Mature B-cell Non-Hodgkin Lymphoma
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov