Treatment of Elderly Patients (>65 Years) With Acute Lymphoblastic Leukemia
Phase 4
Completed
- Conditions
- Adult Acute Lymphocytic Leukemia
- Registration Number
- NCT00199095
- Lead Sponsor
- Goethe University
- Brief Summary
The aim of this study is to test feasibility and efficacy of a dose reduced chemotherapy in elderly patients with newly diagnosed acute lymphoblastic leukemia. The regimen consists of induction phase I and II followed by cyclic consolidation cycles, reinduction and maintenance therapy
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Inclusion Criteria
- diagnosis of acute lymphoblastic leukemia (pro-B,common,pre-B,pre-T,Thy-,mature T, B-ALL)
- age > 65 years
- written informed consent
- Karnofsky > 50% (if not mainly caused by leukemia)
- laboratory at diagnosis or after supportive pre-treatment Creatinine < 2 mg/dl Uric Acid < 8 mg/dl Bilirubin < 1.5 mg/dl ALA, ASA,AP < 2.5 x ULN
Exclusion Criteria
- severe second diseases (e.g. renal failure, cardiomyopathy etc., not caused by leukemia) that exclude treatment according to the protocol
- severe psychiatric illness or other circumstances which may compromise cooperation
- active second neoplasia
- clinical signs of life threatening infections or bleeding, uncontrollable prior to chemotherapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Results of induction therapy,Distribution of entry criteria,Treatment feasibility,Relapse rate and localisation,Death in CR,Remission duration, survival and leukemia free survival,Prognostic factors,Quality of life
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University Hospital, Medical Dept. II
🇩🇪Frankfurt, Germany