Trial document




drksid header

  DRKS00009982

Trial Description

start of 1:1-Block title

Title

Retrospective analysis of treatement modalities and treament outcome in young high-risk patients aged <70 years with diffuse large b-cell lymphoma at Freiburg University CCCF Lymphomacenter.

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Diffuse large B cell lymphoma is a very common subtype of malignant lymphoma. With the initiation of the combined immunotherapy, patient outcome was improved in the last decade. Especially young patients with no risk factors have a good prognosis. Young patients with risk factors still have a poor prognosis. Several attempts tried to improve the outcome of these patients. With this study all patients with high risk diffuse large B cell lymphoma presented at Freiburg University Medical Center from 2005 to 2015 shall be retrospectively identified and analyzed according to their baseline disease characteristics, treatment modalities and patient outcome. This data is compared to our own historical data and international published data.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Diffuse large B cell lymphoma is the most common subtype of high grade malignant lymphomas. In the last decade outcome of patients with diffuse large B cell lymphoma improved since the addition of rituximab to standard CHOP (Cyclophosphamide, vincristine, doxorubicin and prednisolon) therapy (R-CHOP). Despite of these great advances a substantial percentage of young high risk patients still have a poor prognosis with standard immunochemotherapy. Furthermore CNS relapse rate is higher in this patient cohort. To further improve the outcome of young high risk patients several approaches were investigated: A dose intensification of the standard chemotherapy, adding other lymphoma active drugs to the standard regime or using high dose chemotherapy with subsequent autologous stem cell transplantation did not result in higher remission rates or better long term outcome. As a quality control we plan a retrospective analysis of the treatment modalities and the treatment outcome of these patients presenting at Freiburg University medical center from 2005 to 2015. For this analysis the baseline patient characteristics, treatment modalities and patient outcome were collected and analyzed. Our own historical data and international published data served as comparison. Informed consent was obtained with the onset of treatment.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009982
  •   2016/02/02
  •   [---]*
  •   yes
  •   Approved
  •   11/16, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C83.3 -  Diffuse large B-cell lymphoma
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Retrospective analysis of all young high risk DLBCL (aaIPI 2-3) patients according to treatement modalities and outcome presented at Freiburg University Medical Center from 2005 to 2015.
  •   Analysis and comparison of international published data of similar patient cohorts (Diagnosis of diffuse large B cell lymphoma, age <70 years, high risk disease aaIPI 2-3) according to therapy modalities and patient outcome.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Historical
  •   Prognosis
  •   Other
  •   N/A
  •   No
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Overall response rate, complete-remission rate.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Progression-free-, and overall-survival.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/02/15
  •   35
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   70   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

Age 18 – 70.
Primary DLBCL or grade 3b FL without clinical or radiological signs of CNS disease and cytology - CSF.
aaIPI 2-3
and/or
Site specific risk factors for CNS disease.
First-line therapy at University Freiburg Lymphoma Center

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Clinical or radiological signs of CNS disease.
Positive CSF

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Medizinische Klinik I - LymphomzentrumUniversitätsklinikum Freiburg
    • Mr.  PD Dr.  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Medizinische Klinik I - LymphomzentrumUniversitätsklinikum Freiburg
    • Mr.  PD Dr.  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Medizinische Klinik I - LymphomzentrumUniversitätsklinikum Freiburg
    • Mr.  PD Dr.  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Medizinische Klinik I - LymphomzentrumUniversitätsklinikum Freiburg
    • Mr.  PD  Reinhard  Marks 
    • Hugstetter Str. 55
    • 79106  Freiburg im Breisgau
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2016/12/31
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.