Trial document




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  DRKS00012312

Trial Description

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Title

BENITA study on the use of bendamustine in the therapy of malignant lymphomas

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Trial Acronym

BENITA

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The observational study records the use of bendamustine in the therapy of malignant lymphomas as well as the quality of life of younger and elderly patients in the practice and clinic day in order to examine the influence of age on the outcome and the quality of life of the affected persons. Side effects of bendamustine should be assessed under typical application conditions. These include, in particular, haematological toxicities (eg infections, anemia, leukopenia, thrombocytopenia) and non-hematological toxicities (mucosal inflammations, etc.). In particular, the influence of certain therapies (dose adjustments) and characteristics of the patients (age-related general condition, comorbidity) on the frequency, severity and course of side effects have to be recorded. This includes the laboratory diagnostics of anemia, leukopenia, thrombocytopenia or neutropenia.

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Brief Summary in Scientific Language

The study examines in particular the following questions:
1 - What doses and regimens are used with bendamustine in younger and older (> 65 years) patients in the daily routine?
2 - What side effects are observed in the use of bendamustine in monotherapy or combination therapy?
3 - How does age influence dose density or overall dose?
4 - What are the reasons for premature termination and discontinuation of therapy?
5 - What is the observed risk of infections, leukopenia, thrombocytopenia and other adverse events among younger and elderly people under bendamustine?
6 - What is the use of G-CSF, immunoglobulins, antibiotics, antimycotics and virostatics during treatment with bendamustine?
7 - How is the effect of G-CSF, immunoglobulins, antibiotics, antimycotics and virostatics in the prophylaxis on the therapy density and the infection rate?
8 - Are there any unrelated medicinal side effects (here: SUAW) among bendamustine?
9 - What therapeutic or personal factors are responsible for the limitations of quality of life in younger and older patients?


This is an open, prospective, non-interventional observation study and is registered as a planned study at the German Registry of Clinical Studies.
Within the scope of admission studies, the data are obtained from selected patient populations.
Therefore, in the context of this non-interventional study (AWB), no additional requirements are specified regarding patient selection which exceed the SPC characteristics. On the basis of the standard therapy guidelines and medical expertise, the participating practices will consider the use of bendamustine for patients who qualify for informed consent according to SPC and will propose it to those patients after detailed patient information procedure.
By this non-interventional study (AWB) the use of bendamustine will be investigated under practical conditions, ie. after authorization for marketing and on in a broader section of the population.In addition, the spontaneous reporting system according to AMG §63b is supplemented by GCP-documented and promptly forwarded pharmacovigilance data and thus the attention in the practice routine is promoted with regard to pharmacovigilance.

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Organizational Data

  •   DRKS00012312
  •   2017/06/29
  •   [---]*
  •   no
  •   Approved
  •   17034, Ethik-Kommission der Bayerischen Landesärztekammer
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Secondary IDs

  •   U1111-1195-2982 
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Health Condition or Problem studied

  •   C85.7 -  Other specified types of non-Hodgkin lymphoma
  •   C91.1 -  Chronic lymphocytic leukaemia of B-cell type
  •   C90.0 -  Multiple myeloma
  •   Malignant lymphoma
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Interventions/Observational Groups

  •   Treatment with bendamustin according to SPC within a post-marketing surveillance study. Collection of demographic and anamnestic data, health data, dosage and regimen, trace-diagnostics, discontinuation of therapy and interruptions, adverse events, accompanying medication, quality of life.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   No
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Primary Outcome

Efficacy and tolerability: Was the therapy with Bendamustin LIV completed within the planned therapy period? What are the abortive reasons? Clinical therapy outcome, at the end of therapy and follow-up points after 6 and 12 months. Incidence of unexpected side effects throughout the study. Necessity and extent of supportive, anti-infective concomitant medication during therapy.

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Secondary Outcome

Quality of life collected by FACT-Leu_Ver4_NI_10Aug12, FACT-Lym_Ver4_NI_10Aug12, and FACT-MM_Ver4_NI_20Jan17 at start of therapy, end of therapy and follow-up time points after 6 and 12 months.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2017/07/01
  •   500
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Signed and dated consent exists.
- The patient has a histologically or cytologically secured malignant lymphoma.
- The therapy decision was made independently of a possible study inclusion.
- Patient is at least 18 years old

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Exclusion Criteria

- Hypersensitivity to the active substance bendamustine hydrochloride or mannitol
- Breastfeeding, pregnancy or planned pregnancy
- Severe hepatic impairment (serum bilirubin> 3.0 mg / dL)
- Jjaundice
- Severe bone marrow suppression and severe alteration of the blood count (leukocyte or platelet decreases to <3,000 / μL or <75,000 / μL)
- Larger surgical procedures within 30 days before the start of treatment
- Infections, especially in connection with leukocytopenia
- Yellow fever vaccination

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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    • Datafaber GbR
    • Dr  Burkard  Heckelbacher 
    • Kantstrasse 15
    • 85356  Freising
    • Germany
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    • Onkologie Aschaffenburg
    • Mr.  Dr. med.  Manfred  Welslau 
    • Am Hasenkopf 1
    • 63739  Aschaffenburg
    • Germany
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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Sources of Monetary or Material Support

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    • Axios Pharma Gmbh
    • Mr.  Wolfgang  Seppich 
    • Kammerichstr. 39
    • 33647  Bielefeld
    • Germany
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Status

  •   Recruiting ongoing
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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.