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German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Basic Trial Information Trial Description Summary Eligibility Criteria Trial Contact Information
Basic Trial Information
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Phase
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Type
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Status
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Age
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Sponsor
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Protocol IDs
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Phase IV
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Treatment
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Active
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Over 55
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Other
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GMALL02 NCT00198978
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Trial Description
Summary The study evaluates the efficacy and tolerability of a dose-reduced chemotherapy for the treatment of elderly patients with acute lymphoblastic leukemia. In patients with expression of CD20 on leukemic cells the efficacy and tolerability of additional application of Rituximab together with chemotherapy is evaluated. Eligibility Criteria Inclusion Criteria: - Diagnosis of acute lymphoblastic leukemia (pro B, pre B, c-ALL or T-ALL), proved by morphology and immunophenotyping
- Age > 55 yrs (no upper age limit)
Exclusion Criteria: - Severe leukemia associated complications, not controllable before therapy onset e.g.
- life threatening infections as sepsis, pneumonia, hypoxia, shock, life threatening bleeding)
- 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
- 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
Trial Contact Information
Trial Lead Organizations/Sponsors Klinikum der J.W. Goethe Universitaet Dieter Hoelzer | | Study Chair |
Trial Sites
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Germany |
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Frankfurt |
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| | | | | | | Universitaetsfrauenklinik Frankfurt |
| | Dieter Hoelzer, MD,PhD |
Ph: ++49(0)6963015194 |
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Email:
hoelzer@em.uni-frankfurt.de |
| | Nicola Goekbuget, MD |
Ph: ++49(0)6963016365 |
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Email:
goekbuget@em.uni-frankfurt.de |
| | Dieter Hoelzer, MD,PhD | Principal Investigator |
| | Nicola Goekbuget, MD | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00198978 Information obtained from ClinicalTrials.gov on July 16, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov. Back to Top |
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