Status:
UNKNOWN
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
Lead Sponsor:
Johann Wolfgang Goethe University Hospital
Conditions:
Philadelphia Positive Acute Lymphoblastic Leukemia
Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Eligibility:
All Genders
56+ years
Phase:
PHASE2
Brief Summary
The aims of the study are to determine whether single agent imatinib (STI571; Glivec) is more effective as up-front remission induction therapy than conventional multi-agent induction chemotherapy for...
Eligibility Criteria
Inclusion
- Male or female patients
- Age \> 55 years (biological age)
- Diagnosis of Ph1 chromosome-positive ALL (pre-B, common- or pre-pre-B ALL)
- Newly diagnosed, lymphoid blast crisis of chronic myeloid leukemia
- Only pre-phase chemotherapy prior to study start
- World Health Organization (WHO) status 0, 1 or 2
- Voluntary written informed consent
Exclusion
- Creatinine levels more than 2 x the upper limit of normal (ULN)
- Total serum bilirubin more than 1.5 x the ULN
- AST (SGOT) or ALT (SGPT) more than 5 x the ULN
- Any other prior antineoplastic treatment except for pre-phase chemotherapy
- Active central nervous system (CNS) leukemia
- New York Heart Association (NYHA) grade 3/4 cardiac disease
- Active severe infection
- Serious concomitant medical condition
- Patients with a history of non-compliance to medical regimens
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00199186
Start Date
March 1 2002
Last Update
October 19 2007
Active Locations (1)
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1
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Frankfurt am Main, Germany, 60590