Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia

Intervention / Treatment
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* Drug: imatinib
* Drug: vincristine
* Drug: cyclophosphamide
* Drug: cytosine arabinoside
* Drug: dexamethasone
* Drug: idarubicin
* Drug: methotrexate (intrathecal)
* Drug: AraC (intrathecal)
* Drug: dexamethasone (intrathecal)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 56 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: imatinib|nan|
|Drug: vincristine|nan|
|Drug: cyclophosphamide|nan|
|Drug: cytosine arabinoside|nan|
|Drug: dexamethasone|nan|
|Drug: idarubicin|nan|
|Drug: methotrexate (intrathecal)|nan|
|Drug: AraC (intrathecal)|nan|
|Drug: dexamethasone (intrathecal)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate after induction therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate during induction |  |  | 
| Severe adverse events during induction |  |  | 
| Efficacy of salvage therapy after crossover |  |  | 
| Levels of minimal residual disease |  |  | 
| Incidence of relapse |  |  | 
| Remission duration |  |  | 
| Disease free survival |  |  | 
| Overall survival |  |  | 
| Frequency of point mutations in the BCR-ABL gene |  |  |