German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
NCT ID: NCT00198978
Last Updated: 2023-03-20
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
377 participants
INTERVENTIONAL
2003-01-31
2014-06-30
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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Interventional arm
Cyclophosphamide
Dexamethasone / Prednisolone
Cytarabine
Idarubicin
Granulocyte-Colony-Stimulating Factor
Mercaptopurine
Methotrexate
Rituximab
HDARAC
Vincristine
Depocyte
Asparaginase
Interventions
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Cyclophosphamide
Dexamethasone / Prednisolone
Cytarabine
Idarubicin
Granulocyte-Colony-Stimulating Factor
Mercaptopurine
Methotrexate
Rituximab
HDARAC
Vincristine
Depocyte
Asparaginase
Eligibility Criteria
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Inclusion Criteria
* Age \> 55 yrs (no upper age limit)
* Written informed consent
Exclusion Criteria
* life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
* Severe comorbidity e.g.
* decompensated renal failure if not caused by leukemia with Creatinine \> 2x ULN
* heart failure (NYHA II/IV), instable Angina, significant coronary stenosis
* hepatic insufficiency e.g. liver cirrhosis or chronic active hepatitis with bilirubin \> 1,5 x ULN and/or ASA, ALA, AP \> 2,5 ULN
* decompensated metabolic disturbances (e.g. not controllable diabetes)
* severe obstructive or restrictive pulmonary disease with hypoxaemia
* Severe psychiatric illness or other circumstances which may compromise cooperation of the patient
* Active second neoplasia
* HIV infection
* Severely reduced general condition
* Cytostatic pre-treatment of ALL
* Chemotherapy treatment of any other malignancy during the last 5 years
* Participation in other clinical trials interfering with the study therapy
55 Years
ALL
No
Sponsors
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Goethe University
OTHER
Responsible Party
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Nicola Goekbuget
Head of GMALL
Principal Investigators
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Dieter Hoelzer, MD,PhD
Role: STUDY_CHAIR
University 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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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.
Other Identifiers
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GMALL02
Identifier Type: -
Identifier Source: org_study_id
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