Trials / Unknown
UnknownNCT00199186
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)
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Johann Wolfgang Goethe University Hospital · Academic / Other
- Sex
- All
- Age
- 56 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DRUG | imatinib | |
| DRUG | vincristine | |
| DRUG | cyclophosphamide | |
| DRUG | cytosine arabinoside | |
| DRUG | dexamethasone | |
| DRUG | idarubicin | |
| DRUG | methotrexate (intrathecal) | |
| DRUG | AraC (intrathecal) | |
| DRUG | dexamethasone (intrathecal) |
Timeline
- Start date
- 2002-03-01
- First posted
- 2005-09-20
- Last updated
- 2007-10-19
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00199186. Inclusion in this directory is not an endorsement.