Status:
COMPLETED
German Multicenter Trial for Treatment of Elderly Patients With Newly Diagnosed Acute Lymphoblastic Leukemia
Lead Sponsor:
Goethe University
Conditions:
Adult Acute Lymphocytic Leukemia
Eligibility:
All Genders
55+ years
Phase:
PHASE4
Brief 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 leukemi...
Eligibility Criteria
Inclusion
- 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)
- Written informed consent
Exclusion
- Severe leukemia associated complications, not controllable before therapy onset e.g.
- 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
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
377 Patients enrolled
Trial Details
Trial ID
NCT00198978
Start Date
January 1 2003
End Date
June 1 2014
Last Update
March 20 2023
Active Locations (1)
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1
University of Frankfurt, Medical Dept. II
Frankfurt, Germany, 60590