A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
Phase 2
56 Years
N/A
56 Years
N/A
Open (Enrolling)
Both
Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Both
Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Trial Information
A Randomized, Multicenter Open Label Phase II Study to Determine the Safety and Efficacy of Induction Therapy With Imatinib in Comparison With Standard Induction Chemotherapy in Elderly (> 55 Years) Patients With Ph Positive Acute Lymphoblastic Leukemia (ALL)
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Remission rate after induction therapy
Principal Investigator
Oliver G Ottmann, M.D.
Investigator Role:
Study Chair
Investigator Affiliation:
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CSTI571ADE10
NCT ID:
NCT00199186
Start Date:
March 2002
Completion Date:
Related Keywords:
- Philadelphia Positive Acute Lymphoblastic Leukemia
- Lymphoid Blastic Phase of Chronic Myeloid Leukemia
- Leukemia
- Leukemia, Lymphoid
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Leukemia, Myeloid
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
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