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

Johann Wolfgang Goethe University Hospital

Status and phase: Unknown; Phase 2

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

Treatments: Drug: imatinib; Drug: dexamethasone; Drug: methotrexate (intrathecal); Drug: dexamethasone (intrathecal); Drug: vincristine; Drug: AraC (intrathecal); Drug: idarubicin; Drug: cyclophosphamide; Drug: cytosine arabinoside

Study type: Interventional

Funder types: Other

Identifiers

NCT00199186

CSTI571ADE10

GMALL-STI571-ELDERLY-01/02

Details and patient eligibility

About

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.

Sex: All

Ages: 56+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)