German Multicenter Trial for Treatment of Newly Diagnosed Acute Lymphoblastic Leukemia in Adults (07/2003)
NCT ID: NCT00198991
Last Updated: 2022-08-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
1883 participants
INTERVENTIONAL
2003-04-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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All patients
All patients are treated upfront according to one arm
Cyclophosphamide
Cytostatic drug
Dexamethasone
Antileukemic drug
Vincristine
Cytostatic drug
Daunorubicin
Cytostatic drug
Asparaginase
Cytostatic drug
Methotrexate
Cytostatic drug
Cytarabine
Cytostatic drug
Mercaptopurine
Cytostatic drug
G-CSF
Growth factor
Vindesine
Cytostatic drug
Etoposide
Cytostatic drug
Prednisolone
Antileukemic drug
Adriamycin
Cytostatic drug
Thioguanine
Cytostatic drug
Teniposide
Cytostatic drug
CNS irradiation
Cytostatic drug
Mediastinal Irradiation
Irradiation
Stem cell transplantation (SCT)
Stem cell transplantation
Idarubicin
Cytostatic drug
Fludarabine
Cytostatic drug
Cladribine
Cytostatic drug
Interventions
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Cyclophosphamide
Cytostatic drug
Dexamethasone
Antileukemic drug
Vincristine
Cytostatic drug
Daunorubicin
Cytostatic drug
Asparaginase
Cytostatic drug
Methotrexate
Cytostatic drug
Cytarabine
Cytostatic drug
Mercaptopurine
Cytostatic drug
G-CSF
Growth factor
Vindesine
Cytostatic drug
Etoposide
Cytostatic drug
Prednisolone
Antileukemic drug
Adriamycin
Cytostatic drug
Thioguanine
Cytostatic drug
Teniposide
Cytostatic drug
CNS irradiation
Cytostatic drug
Mediastinal Irradiation
Irradiation
Stem cell transplantation (SCT)
Stem cell transplantation
Idarubicin
Cytostatic drug
Fludarabine
Cytostatic drug
Cladribine
Cytostatic drug
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Age 15-65 yrs (\*55-65 years if biologically younger according to general condition)
* Written informed consent
Exclusion Criteria
* Late relapse of pediatric ALL or ALL as second malignancy
* Cytostatic pre-treatment
* Pregnancy
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Participation in other clinical trials interfering with the study therapy
15 Years
65 Years
ALL
No
Sponsors
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Deutsche Krebshilfe e.V., Bonn (Germany)
OTHER
German Federal Ministry of Education and Research
OTHER_GOV
Goethe University
OTHER
Responsible Party
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Nicola Goekbuget
Principal Investigator
Principal Investigators
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Dieter Hoelzer, MD,PhD
Role: STUDY_CHAIR
University Hospital of Frankfurt, Medical Dept. II
Locations
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University of Frankfurt, Medical Dept. II
Frankfurt, , Germany
Countries
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References
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Kobitzsch B, Gokbuget N, Schwartz S, Reinhardt R, Bruggemann M, Viardot A, Wasch R, Starck M, Thiel E, Hoelzer D, Burmeister T. Loss-of-function but not dominant-negative intragenic IKZF1 deletions are associated with an adverse prognosis in adult BCR-ABL-negative acute lymphoblastic leukemia. Haematologica. 2017 Oct;102(10):1739-1747. doi: 10.3324/haematol.2016.161273. Epub 2017 Jul 27.
Herold T, Schneider S, Metzeler KH, Neumann M, Hartmann L, Roberts KG, Konstandin NP, Greif PA, Braundl K, Ksienzyk B, Huk N, Schneider I, Zellmeier E, Jurinovic V, Mansmann U, Hiddemann W, Mullighan CG, Bohlander SK, Spiekermann K, Hoelzer D, Bruggemann M, Baldus CD, Dreyling M, Gokbuget N. Adults with Philadelphia chromosome-like acute lymphoblastic leukemia frequently have IGH-CRLF2 and JAK2 mutations, persistence of minimal residual disease and poor prognosis. Haematologica. 2017 Jan;102(1):130-138. doi: 10.3324/haematol.2015.136366. Epub 2016 Aug 25.
Topp MS, Gokbuget N, Zugmaier G, Degenhard E, Goebeler ME, Klinger M, Neumann SA, Horst HA, Raff T, Viardot A, Stelljes M, Schaich M, Kohne-Volland R, Bruggemann M, Ottmann OG, Burmeister T, Baeuerle PA, Nagorsen D, Schmidt M, Einsele H, Riethmuller G, Kneba M, Hoelzer D, Kufer P, Bargou RC. Long-term follow-up of hematologic relapse-free survival in a phase 2 study of blinatumomab in patients with MRD in B-lineage ALL. Blood. 2012 Dec 20;120(26):5185-7. doi: 10.1182/blood-2012-07-441030. Epub 2012 Sep 28.
Gokbuget N, Stanze D, Beck J, Diedrich H, Horst HA, Huttmann A, Kobbe G, Kreuzer KA, Leimer L, Reichle A, Schaich M, Schwartz S, Serve H, Starck M, Stelljes M, Stuhlmann R, Viardot A, Wendelin K, Freund M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Outcome of relapsed adult lymphoblastic leukemia depends on response to salvage chemotherapy, prognostic factors, and performance of stem cell transplantation. Blood. 2012 Sep 6;120(10):2032-41. doi: 10.1182/blood-2011-12-399287. Epub 2012 Apr 4.
Gokbuget N, Kneba M, Raff T, Trautmann H, Bartram CR, Arnold R, Fietkau R, Freund M, Ganser A, Ludwig WD, Maschmeyer G, Rieder H, Schwartz S, Serve H, Thiel E, Bruggemann M, Hoelzer D; German Multicenter Study Group for Adult Acute Lymphoblastic Leukemia. Adult patients with acute lymphoblastic leukemia and molecular failure display a poor prognosis and are candidates for stem cell transplantation and targeted therapies. Blood. 2012 Aug 30;120(9):1868-76. doi: 10.1182/blood-2011-09-377713. Epub 2012 Mar 22.
Burmeister T, Meyer C, Schwartz S, Hofmann J, Molkentin M, Kowarz E, Schneider B, Raff T, Reinhardt R, Gokbuget N, Hoelzer D, Thiel E, Marschalek R. The MLL recombinome of adult CD10-negative B-cell precursor acute lymphoblastic leukemia: results from the GMALL study group. Blood. 2009 Apr 23;113(17):4011-5. doi: 10.1182/blood-2008-10-183483. Epub 2009 Jan 14.
Other Identifiers
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GMALL01
Identifier Type: -
Identifier Source: org_study_id
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