Trial document




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  DRKS00000908

Trial Description

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Title

Rituximab in Treating Young Patients Who Are Receiving Chemotherapy for B-Cell Non-Hodgkin's Lymphoma or B-Cell Acute Lymphoblastic Leukemia
Multicenter Therapy Study for Children With Mature B-NHL or B-ALL With a Rituximab - Window Before Chemotherapy

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Primary outcome of the B-NHLFM Rituximab study, is a systematic analysis of the percentage of children and adolescents with mature B-NHL/B-ALL which have shown a definite response to Rituximab. Additionally, in accompanying research projects of this study, it will be examined if any biological or pharmacokinetic parameters exist, which promote a good response to Rituximab. The findings from the B-NHL BFM Rituximab study should serve to facilitate a broader application of Rituximab in children with B-NHL/B-ALL in future studies. Rituximab, in contrast to most other medications used to date, has the property of being damaging only to certain cells and thereby mainly tumor cells. Should Rituximab be shown to be effective, there is hope of substituting Rituximab with other medications with severe side-effects without forfitting the good recovery prognosis of the patients.

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Brief Summary in Scientific Language

This treatment study will evaluate the response of B-NHL and B-ALL in children to a five-day Rituximab-window before the begin of the chemotherapy and in doing so examining the overall efficacy of Rituximab. Because of the favorable toxicity profile and the targeted therapy against CD20 positive tumor cells, the chimeric monoclonal antibody Rituximab presents a possible therapeutic extension for B-NHL in children. Along with efficacy, the study will also examine the response to Rituximab in different compartments as well as the response in different histological subtypes. Through the measurement of R.-levels in serum and liquor in addition to accompanying research projects, data on pharmacokinetics and data concerning certain mechanisms and possible influencing factors to the R.-response will be examined. The Rituximab window is followed by a chemotherapy as recommended in Protocol B-NHLBFM 04. (Application for ethical approval will also be submitted at this time.) The study is divided into two stages in which Rituximab is dosed based on response. At a response rate of >65% after the first or second stage respectively, the participation in a subsequent randomized therapy-optimization-study with Rituximab is foreseen.

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Organizational Data

  •   DRKS00000908
  •   2012/03/22
  •   2004/11/22
  •   yes
  •   Approved
  •   27/04, Ethik-Kommission des Fachbereichs Medizin der Justus-Liebig-Universität Gießen
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Secondary IDs

  •   NCT00324779  (clinicaltrials.gov)
  •   UKF000179  (Register klinischer Studien des Universitätsklinikums Freiburg)
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Health Condition or Problem studied

  •   C85.1 -  B-cell lymphoma, unspecified
  •   C91.0 -  Acute lymphoblastic leukaemia
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Interventions/Observational Groups

  •   Rituximab
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

Primary outcome measure:
Primary outcome measure is the response to therapy on day 5: Reduction of tumor size by ≥25%. This will be assessed on the basis of the largest measurable tumor manifestation, the so-called index manifestation. In this manifestation, the two largest vertical diameters will be measured and their values multiplied. A distinct response is defined as a reduction in the product of the diameter of ≥25%. In the case if bone marrow affliction, a distinct response is defined as a reduction in the proportion of blasts (e.g. a reduction of the proportion of blasts from 60% to 32% in the bone marrow).

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Secondary Outcome

Secondary outcome measures:
1. It will be examined if there is a correlation between a response to Rituximab before the onset of chemotherapy and the overall therapy success of each patient.
2. It will be examined if there is a difference regarding the response to Rituximab in different histological subtypes of mature B-NHL.
3. It will be examined if the response to Rituximab correlates with the tumor mass (LDH).
4. It will be examined if lymphoma manifestations in different areas (bone marrow, bulky disease) respond to Rituximab to the same extent.
5. The toxicity profile of Rituximab in children and adolescents will be measured.
6. The liquor patency of Rituximab will be controlled.
7. Through thorough accompanying research, data in regards to pharmacokinetics will be gathered and parameters for the predictive relevancy of the Rituximab response will be identified.

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Countries of Recruitment

  •   Germany
  •   Switzerland
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2004/04/25
  •   90
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   18   Years
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Additional Inclusion Criteria

Inclusion criteria:
1. Newly diagnosed and histologically/immunohistologically or cytomorphologically/immunologically verified mature B-NHL or B-ALL (not: lymphoblastic lymphoma of precursor B-CELL type, protocol EURO-LB 02)
2. Immunological or immuno-histo-chemical proof of a CD20-expression of the lymphoma cells
3. Written informed consent and consent for the processing and disclosure of data by each patient and/or their legal guardian.
4. Diagnosis prior to 19th birthday.
5. Begin of protocol therapy within the duration of the study
6. Treatment in one of the participating study clinics
7. Contraception in women of child-bearing age
8. No participation in any other study with the exception of B-NHL BFM 04
9. Stratification according to stage, extent of resection, and initial LDH in the therapy arms R2, R3, or R4
10. Good general health; adequate liver, cardiac, and renal functions.
11. Existence of a lymphoma manifestation which is accessible for the assessment of response (measurement of size within 24 hours before application of Rituximab)

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Exclusion Criteria

Pregnant or nursing,
Allergies against proteins,
Known disease that would preclude protocol therapy with rituximab,
Significant therapy prior to protocol therapy

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitäts-Kinderklinik Pädiatrische Hämatologie und Onkologie
    • Mr.  Prof. Dr. med.  Alfred  Reiter 
    • Feulgenstr. 12
    • 35385  Giessen
    • Germany
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    • Universitäts-Kinderklinik Pädiatrische Hämatologie und Onkologie
    • Mr.  Prof. Dr. med.  Alfred  Reiter 
    • Feulgenstr. 12
    • 35385  Giessen
    • Germany
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    • Universitäts-Kinderklinik Pädiatrische Hämatologie und Onkologie
    • Mr.  Prof. Dr. med.  Alfred  Reiter 
    • Feulgenstr. 12
    • 35385  Giessen
    • Germany
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Sources of Monetary or Material Support

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    • Deutsche Kinderkrebsstiftung
    • 53113  Bonn
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.