Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
NCT ID: NCT00199186
Last Updated: 2007-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
2002-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
imatinib
vincristine
cyclophosphamide
cytosine arabinoside
dexamethasone
idarubicin
methotrexate (intrathecal)
AraC (intrathecal)
dexamethasone (intrathecal)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
56 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Johann Wolfgang Goethe University Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Oliver G Ottmann, M.D.
Role: STUDY_CHAIR
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Frankfurt am Main, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Oliver G Ottmann, M.D.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GMALL-STI571-ELDERLY-01/02
Identifier Type: -
Identifier Source: secondary_id
CSTI571ADE10
Identifier Type: -
Identifier Source: org_study_id