Back to resultsStudy Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
Primary Purpose
Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Status
Unknown status
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
imatinib
vincristine
cyclophosphamide
cytosine arabinoside
dexamethasone
idarubicin
methotrexate (intrathecal)
AraC (intrathecal)
dexamethasone (intrathecal)
Sponsored by
About this trial
This is an interventional treatment trial for Philadelphia Positive Acute Lymphoblastic Leukemia
Eligibility Criteria
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
Sites / Locations
- Medizinische Klinik II, Johann Wolfgang Goethe UniversitätRecruiting
Outcomes
Primary Outcome Measures
Remission rate after induction therapy
Secondary Outcome Measures
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
Full Information
NCT ID
NCT00199186
First Posted
September 16, 2005
Last Updated
October 18, 2007
Sponsor
Johann Wolfgang Goethe University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00199186
Brief Title
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Johann Wolfgang Goethe University Hospital
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
imatinib
Intervention Type
Drug
Intervention Name(s)
vincristine
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
cytosine arabinoside
Intervention Type
Drug
Intervention Name(s)
dexamethasone
Intervention Type
Drug
Intervention Name(s)
idarubicin
Intervention Type
Drug
Intervention Name(s)
methotrexate (intrathecal)
Intervention Type
Drug
Intervention Name(s)
AraC (intrathecal)
Intervention Type
Drug
Intervention Name(s)
dexamethasone (intrathecal)
Primary Outcome Measure Information:
Title
Remission rate after induction therapy
Secondary Outcome Measure Information:
Title
Mortality rate during induction
Title
Severe adverse events during induction
Title
Efficacy of salvage therapy after crossover
Title
Levels of minimal residual disease
Title
Incidence of relapse
Title
Remission duration
Title
Disease free survival
Title
Overall survival
Title
Frequency of point mutations in the BCR-ABL gene
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oliver G Ottmann, M.D.
Phone
++49-69-6301-0
Ext
6221
Email
ottmann@em.uni-frankfurt.de
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Wassmann, M.D.
Phone
++49-69-6301-0
Ext
6221
Email
wassmann@em.uni-frankfurt.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oliver G Ottmann, M.D.
Organizational Affiliation
Medizinische Klinik II, Johann Wolfgang Goethe Universität
Official's Role
Study Chair
Facility Information:
Facility Name
Medizinische Klinik II, Johann Wolfgang Goethe Universität
City
Frankfurt/Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oliver G Ottmann, M.D.
Phone
++49-69-6301-0
Ext
6221
Email
ottmann@em.uni-frankfurt.de
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Imatinib With Chemotherapy as Induction in Elderly Patients With Philadelphia Positive Acute Lymphoblastic Leukemia (ALL)
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