Philadelphia Positive Acute Lymphoblastic Leukemia, Lymphoid Blastic Phase of Chronic Myeloid Leukemia
Conditions
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.
Interventions
DRUGimatinib
DRUGvincristine
DRUGcyclophosphamide
DRUGdexamethasone
DRUGidarubicin
DRUGAraC (intrathecal)
DRUGdexamethasone (intrathecal)
Sponsors
Johann Wolfgang Goethe University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
56 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Remission rate after induction therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| Severe adverse events during induction | — |
| Efficacy of salvage therapy after crossover | — |
| Levels of minimal residual disease | — |
| Incidence of relapse | — |
| Mortality rate during induction | — |
| Disease free survival | — |
| Overall survival | — |
| Frequency of point mutations in the BCR-ABL gene | — |
| Remission duration | — |
Countries
Germany
Contacts
Primary ContactOliver G Ottmann, M.D.
Backup ContactBarbara Wassmann, M.D.
Outcome results
None listed