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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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27 May 2024 |
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Main ID: |
DRKS00003929 |
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Date of registration:
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24/11/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 - ALL GMALL Register |
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Date of first enrolment:
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15/09/2009 |
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Target sample size:
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500 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00003929 |
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Study type:
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observational |
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Study design:
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Allocation: ; Masking: ; Control: ; Assignment: ; Study design purpose: other
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Phase:
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Countries of recruitment
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Germany
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Contacts
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Name:
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Nicola
Gökbuget |
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Address:
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Theodor-Stern-Kai 7
60590
Frankfurt/Main
Germany |
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Telephone:
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+49 (0)69 6301-6365 |
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Email:
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goekbuget@em.uni-frankfurt.de |
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Affiliation:
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Universitätsklinikum Frankfurt/Main |
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Name:
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Nicola
Gökbuget |
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Address:
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Theodor-Stern-Kai 7
60590
Frankfurt/Main
Germany |
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Telephone:
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+49 (0)69 6301- 6365 |
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Email:
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goekbuget@em.uni-frankfurt.de |
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Affiliation:
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Universitätsklinikum Frankfurt/Main |
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Key inclusion & exclusion criteria
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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
Exclusion criteria: non
Age minimum:
18 Years
Age maximum:
None
Gender:
All
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Health Condition(s) or Problem(s) studied
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C91.0
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C91.0
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Acute lymphoblastic leukaemia [ALL]
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Intervention(s)
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Group 1: 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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Primary Outcome(s)
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# 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(s)
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# 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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Source(s) of Monetary Support
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GMALL-Studiengruppe
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Ethics review
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Status: Approved
Approval date: 20/04/2009
Contact:
ethikkommission@laekh.de
Ethik-Kommission der Landesärztekammer Hessen
+49-69-97672209
ethikkommission@laekh.de
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