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

Phase 2

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

• Registration Number: NCT00199186
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-03
• Status Verified: 2005-09
• Study First Submitted: 2005-09-16
• Study First Submitted QC: 2005-09-16
• Study First Posted: 2005-09-20
• Last Update Submitted: 2007-10-18
• Last Update Posted: 2007-10-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Remission rate after induction therapy

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Medizinische Klinik II, Johann Wolfgang Goethe Universität; 🇩🇪 Frankfurt/Main, Germany