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

October 18, 2007 updated by: Johann Wolfgang Goethe University Hospital

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Frankfurt/Main, Germany, 60590
        • Recruiting
        • Medizinische Klinik II, Johann Wolfgang Goethe Universität
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

56 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Remission rate after induction therapy

Secondary Outcome Measures

Outcome Measure
Overall survival
Disease free survival
Remission duration
Mortality rate during induction
Severe adverse events during induction
Efficacy of salvage therapy after crossover
Levels of minimal residual disease
Incidence of relapse
Frequency of point mutations in the BCR-ABL gene

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

  • Study Chair: Oliver G Ottmann, M.D., Medizinische Klinik II, Johann Wolfgang Goethe Universität

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2002

Study Registration Dates

First Submitted

September 16, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Estimate)

October 19, 2007

Last Update Submitted That Met QC Criteria

October 18, 2007

Last Verified

September 1, 2005

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSTI571ADE10
  • GMALL-STI571-ELDERLY-01/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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