Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00003929

Trial Description

start of 1:1-Block title

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

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

Trial Acronym

ALL GMALL Register

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

URL of the Trial

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

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

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

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

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

end of 1:1-Block scientific synopsis
start of 1:1-Block forwarded Data

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

[---]*

end of 1:1-Block forwarded Data
start of 1:1-Block forwarded Data Content

Description IPD sharing plan:

[---]*

end of 1:1-Block forwarded Data Content
start of 1:1-Block organizational data

Organizational Data

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

  •   C91.0 -  Acute lymphoblastic leukaemia [ALL]
end of 1:N-Block indications
start of 1:N-Block interventions

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
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Other
  •   Single (group)
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

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

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

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

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

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

Recruitment

  •   Actual
  •   2009/09/15
  •   500
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

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

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

Exclusion Criteria

non

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

Addresses

  • start of 1:1-Block address primary-sponsor
    • GMALL-Studiengruppe
    • Mr.  Prof. Dr. med.  Dieter  Hoelzer 
    • Schaubstr. 16
    • 60596  Frankfurt
    • 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
    • Universitätsklinikum Frankfurt/Main
    • Ms.  Dr. med.  Nicola  Gökbuget 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt/Main
    • 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
    • Universitätsklinikum Frankfurt/Main
    • Ms.  Dr. med.  Nicola  Gökbuget 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt/Main
    • 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
    • GMALL-Studiengruppe
    • Mr.  Prof. Dr. med.  Dieter  Hoelzer 
    • Schaubstr. 16
    • 60596  Frankfurt
    • 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 ongoing
  •   [---]*
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.