Trial document




This trial has been registered retrospectively.
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  DRKS00003929

Trial Description

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Title

Prospective data acquisition of diagnosis, treatment and course of disease in adult acute lymphoblastic leukemia (ALL) and related diseases in conjunction with a prospective collection of biomaterial

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Trial Acronym

ALL GMALL Register

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URL of the Trial

http://www.kompetenznetz-leukaemie.de/content/aerzte/studien/studienregister/index_ger.html

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Brief Summary in Lay Language

Prospective data acquisition of diagnosis, treatment and course of disease in adult acute lymphoblastic leukemia (ALL) and related diseases in conjunction with a prospective collection of biomaterial

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Brief Summary in Scientific Language

GMALL registry and biomaterial data base . Prospective data acquisition of diagnosis, treatment and course of disease in adult acute lymphoblastic leukemia (ALL) and related diseases in conjunction with a prospective collection of biomaterial

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Do you plan to share individual participant data with other researchers?

[---]*

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Description IPD sharing plan:

[---]*

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Organizational Data

  •   DRKS00003929
  •   2014/11/24
  •   [---]*
  •   yes
  •   Approved
  •   69/09, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C91.0 -  Acute lymphoblastic leukaemia [ALL]
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Interventions/Observational Groups

  •   Prospective data acquisition of diagnosis, treatment and course of disease in adult acute lymphoblastic leukemia (ALL) and related diseases in conjunction with a prospective collection of biomaterial
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

# Collection of input features and prognostic factors ( including newer methods, such as MRD determination at different times )
# Survey of disease status and selected therapies
# Survey of therapy procedure included the overall and disease-free survival, response rate and duration of the various therapies and patient subgroups

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Secondary Outcome

# Collect data on treatment with newer forms of therapy ( eg molecular therapies ) and use of modern supportive medications ( eg PEG - G - CSF , palifermin )
# Collection of therapy and late effects
# Survey of quality of diagnosis and treatment of ALL

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2009/09/15
  •   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

# Age min . 18 years
# Written informed consent
# Therapy analogous to a GMALL therapy optimization study or GMALL therapy recommendation
# One of the following three inclusion criteria :
# 1 acute lymphoblastic leukemia
# 2 other leukemias (NK-cell lymphoma / leukemia or acute biphenotypic leukemia)
# 3. Non-Hodgkin's lymphoma following subtypes ( WHO classification ) : Burkitt 's lymphoma (incl. Atypical Burkitt 's lymphoma, Burkitt-like lymphoma ) , diffuse large B-cell lymphoma ( DLBCL particular primary mediastinal , DLBCL with Burkitt -Signature , C-myc-positive DLBCL ), B-cell lymphoblastic lymphoma, T-cell lymphoblastic lymphoma, Large Cell Anaplastic lymphoma, NHL Other

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Exclusion Criteria

non

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Addresses

  • start of 1:1-Block address primary-sponsor
    • GMALL-Studiengruppe
    • Mr.  Prof. Dr. med.  Dieter  Hoelzer 
    • Schaubstr. 16
    • 60596  Frankfurt
    • Germany
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    • Universitätsklinikum Frankfurt/Main
    • Ms.  Dr. med.  Nicola  Gökbuget 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt/Main
    • Germany
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    • Universitätsklinikum Frankfurt/Main
    • Ms.  Dr. med.  Nicola  Gökbuget 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt/Main
    • Germany
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Sources of Monetary or Material Support

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    • GMALL-Studiengruppe
    • Mr.  Prof. Dr. med.  Dieter  Hoelzer 
    • Schaubstr. 16
    • 60596  Frankfurt
    • 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.