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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johann Wolfgang Goethe University Hospital
• Treatments: BB 1101; Cyclophosphamide; Cytarabine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Idarubicin; Imatinib Mesylate; Methotrexate; Vincristine

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