Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
NCT00199186 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL
Last updated 2007-10-19
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 elderly patients with Philadelphia positive (Ph+)ALL, whether this treatment is better tolerated, and whether subsequent combination therapy with imatinib and chemotherapy of approximately a 1 year duration is tolerable and effective with respect to maintaining remissions.
Conditions
- Philadelphia Positive Acute Lymphoblastic Leukemia
- Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Interventions
- DRUG
-
imatinib
- DRUG
-
vincristine
- DRUG
- DRUG
-
cytosine arabinoside
- DRUG
- DRUG
-
idarubicin
- DRUG
-
methotrexate (intrathecal)
- DRUG
-
AraC (intrathecal)
- DRUG
-
dexamethasone (intrathecal)
Sponsors & Collaborators
-
Johann Wolfgang Goethe University Hospital
lead OTHER
Principal Investigators
-
Oliver G Ottmann, M.D. · Medizinische Klinik II, Johann Wolfgang Goethe Universität
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 56 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-03-31
Countries
- Germany
Study Locations
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