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

Philadelphia Positive Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00199186
• Other study ID #: CSTI571ADE10
• Secondary ID: GMALL-STI571-ELD
• Status: Recruiting
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: October 18, 2007
• Start date: March 2002

Study information

• Verified date: September 2005
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: Oliver G Ottmann, M.D.
• Phone: ++49-69-6301-0
• Email: ottmann[@]em.uni-frankfurt.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 56 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Lymphoid Blastic Phase of Chronic Myeloid Leukemia
• Philadelphia Positive Acute Lymphoblastic Leukemia
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Drug:
• imatinib

• vincristine

• cyclophosphamide

• cytosine arabinoside

• dexamethasone

• idarubicin

• methotrexate (intrathecal)

• AraC (intrathecal)

• dexamethasone (intrathecal)

Locations

Country	Name	City	State
Germany	Medizinische Klinik II, Johann Wolfgang Goethe Universität	Frankfurt/Main

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission rate after induction therapy
Secondary	Mortality rate during induction
Secondary	Severe adverse events during induction
Secondary	Efficacy of salvage therapy after crossover
Secondary	Levels of minimal residual disease
Secondary	Incidence of relapse
Secondary	Remission duration
Secondary	Disease free survival
Secondary	Overall survival
Secondary	Frequency of point mutations in the BCR-ABL gene