Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
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)
2 other identifiers
interventional
N/A
1 country
1
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 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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2002
CompletedFirst Submitted
Initial submission to the registry
September 16, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedOctober 19, 2007
September 1, 2005
September 16, 2005
October 18, 2007
Conditions
Outcome Measures
Primary Outcomes (1)
Remission rate after induction therapy
Secondary Outcomes (9)
Mortality rate during induction
Severe adverse events during induction
Efficacy of salvage therapy after crossover
Levels of minimal residual disease
Incidence of relapse
- +4 more secondary outcomes
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Frankfurt am Main, 60590, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Oliver G Ottmann, M.D.
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 16, 2005
First Posted
September 20, 2005
Study Start
March 1, 2002
Last Updated
October 19, 2007
Record last verified: 2005-09