Imatinib Mesylate and Cytarabine in Treating Patients With Newly Diagnosed Chronic Myeloid Leukemia

September 16, 2013 updated by: Commissie Voor Klinisch Toegepast Onderzoek

A Dose-ranging Phase I/II Study of STI571 in Combination With Cytarabin in Patients With First Chronic Phase Chronic Myeloid Leukemia

RATIONALE: Imatinib mesylate may stop the growth of cancer cells by blocking the enzymes necessary for cancer cell growth. Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Combining imatinib mesylate and chemotherapy may kill more cancer cells.

PURPOSE: Phase I/II trial to study the effectiveness of imatinib mesylate plus cytarabine in treating patients who have newly diagnosed chronic myeloid leukemia.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Determine the maximum tolerated dose of imatinib mesylate and cytarabine in patients with newly diagnosed chronic phase chronic myeloid leukemia.
  • Determine the feasibility of this regimen as defined by dose-limiting toxicity of this regimen and treatment-related mortality in no more than 5% of these patients.
  • Determine the rate and duration of molecular response, complete hematological response, and complete cytogenetic response in patients treated with this regimen.
  • Determine the time to treatment failure of patients treated with this regimen.
  • Determine the overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of imatinib mesylate and cytarabine.

Patients receive oral imatinib mesylate alone once daily on days 1-21. Patients then receive oral imatinib mesylate once daily and cytarabine IV over 1-3 hours on days 1-7. Combination therapy repeats every 28-42 days for 2 courses. Patients then receive maintenance oral imatinib mesylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

Cohorts of 5-20 patients receive escalating doses of imatinib mesylate and cytarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 5/5, 5/10, or 5/20 patients experience dose-limiting toxicity.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 30-60 patients will be accrued for this study within 2 years.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

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

Study Locations

  • Belgium
      • Brugge, Belgium, 8000
        • AZ Sint-Jan
      • Brussels, Belgium, 1200
        • Cliniques Universitaires Saint-Luc
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Mont-Godinne Yvoir, Belgium, 5530
        • Clinique Universitaire De Mont-Godinne
  • Netherlands
      • 's-Gravenhage, Netherlands, 2545 CH
        • HagaZiekenhuis - Locatie Leyenburg
      • Amersfoort, Netherlands, 3816 CP
        • Meander Medisch Centrum
      • Amsterdam, Netherlands, 1105 AZ
        • Academisch Medisch Centrum at University of Amsterdam
      • Amsterdam, Netherlands, 10P 1HV
        • Vrije Universiteit Medisch Centrum
      • Enschede, Netherlands, 7500 KA
        • Medisch Spectrum Twente
      • Groningen, Netherlands, 9713 EZ
        • University Medical Center Groningen
      • Leiden, Netherlands, 2300 RC
        • Leiden University Medical Center
      • Nijmegen, Netherlands, 6500 HB
        • Universitair Medisch Centrum St. Radboud - Nijmegen
      • Rotterdam, Netherlands, 3008 AE
        • Daniel Den Hoed Cancer Center at Erasmus Medical Center
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
      • Zwolle, Netherlands, 8000 GK
        • Isala Klinieken - locatie Sophia

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

DISEASE CHARACTERISTICS:

  • Newly diagnosed chronic myeloid leukemia in first chronic phase (within the past 6 months)

    • Philadelphia-chromosome positive OR
    • bcr-abl rearrangement
  • No prior treatment within the past 6 months other than hydroxyurea

PATIENT CHARACTERISTICS:

Age:

  • 18 to 65

Performance status:

  • WHO 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • No hepatic dysfunction
  • Bilirubin less than 2 times normal
  • ALT less than 4 times normal

Renal:

  • No renal dysfunction
  • Creatinine less than 2.3 mg/dL

Cardiovascular:

  • No severe cardiac dysfunction
  • No New York Heart Association class II-IV heart disease

Pulmonary:

  • No severe pulmonary disease

Other:

  • HIV negative
  • No severe neurologic disease
  • No active uncontrolled infection
  • No other active malignancy within the past 5 years except basal cell skin cancer or stage 0 cervical cancer
  • Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • See Disease Characteristics
  • No concurrent allogeneic transplantation with an HLA-A, B, DR-matched sibling donor or matched-unrelated donor

Chemotherapy:

  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics

Radiotherapy:

  • See Disease Characteristics

Surgery:

  • See Disease Characteristics

Other:

  • No concurrent grapefruit or grapefruit juice

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Incidence of dose-limiting toxicity and treatment-related toxicity per dose level

Secondary Outcome Measures

Outcome Measure
Time to treatment failure
Overall survival
Rate and duration of molecular response
Rate and duration of complete hematological response
Rate and duration of complete cytogenetic response

Collaborators and Investigators

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

Sponsor

Commissie Voor Klinisch Toegepast Onderzoek

Investigators

  • Study Chair: J.J. Cornelissen, MD, Daniel Den Hoed Cancer Center at Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2001

Study Registration Dates

First Submitted

January 4, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

September 17, 2013

Last Update Submitted That Met QC Criteria

September 16, 2013

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000069141
  • CKTO-2001-03
  • HOVON-51CML
  • EU-20132
  • HOVON-CKTO-2001-03
  • NOVARTIS-CST1571ANL01

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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