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AzTrials

LeukemiaPhase 1/2NCT00028847

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

A Phase 1/2 study testing cytarabine and imatinib mesylate in people with Leukemia, run by Commissie Voor Klinisch Toegepast Onderzoek at 16 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Leukemia
What is being tested?
cytarabine and imatinib mesylate
How many people
60 participants
Where
16 sitesin 2 countries
Study dates
Apr 2001to not given
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

16 sites in 2 countries.

16 sites in 2 countries

Netherlands11 sites

  • Meander Medisch Centrum

    Amersfoort, 3816 CP

  • Vrije Universiteit Medisch Centrum

    Amsterdam, 10P 1HV

  • Academisch Medisch Centrum at University of Amsterdam

    Amsterdam, 1105 AZ

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • University Medical Center Groningen

    Groningen, 9713 EZ

  • Leiden University Medical Center

    Leiden, 2300 RC

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, 6500 HB

  • Daniel Den Hoed Cancer Center at Erasmus Medical Center

    Rotterdam, 3008 AE

  • HagaZiekenhuis - Locatie Leyenburg

    The Hague, 2545 CH

  • University Medical Center Utrecht

    Utrecht, 3584 CX

  • Isala Klinieken - locatie Sophia

    Zwolle, 8000 GK

Other trials in Netherlands

Belgium5 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

Other trials in Belgium

About this study

Official title: 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.

Read the 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.

Conditions
Leukemia
Being tested
cytarabine, imatinib mesylate
Keywords
chronic phase chronic myelogenous leukemia, chronic myelogenous leukemia, BCR-ABL1 positive
Medical subject headings
Leukemia, Leukemia, Myeloid, Chronic-Phase, Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicity and treatment-related toxicity per dose level

Secondary outcomes (5)

  1. Rate and duration of molecular response

  2. Rate and duration of complete hematological response

  3. Rate and duration of complete cytogenetic response

  4. Time to treatment failure

  5. Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startApr 2001

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00028847
Sponsor's protocol ID
CDR0000069141
Other IDs
CKTO-2001-03, HOVON-51CML, EU-20132, HOVON-CKTO-2001-03, NOVARTIS-CST1571ANL01
Status last verified
Aug 2011
First submitted
4 Jan 2002
Last updated
17 Sep 2013
Results posted
No

Publications

  • Deenik W, Janssen JJ, van der Holt B, Verhoef GE, Smit WM, Kersten MJ, Daenen SM, Verdonck LF, Ferrant A, Schattenberg AV, Sonneveld P, van Marwijk Kooy M, Wittebol S, Willemze R, Wijermans PW, Beverloo HB, Lowenberg B, Valk PJ, Ossenkoppele GJ, Cornelissen JJ. Efficacy of escalated imatinib combined with cytarabine in newly diagnosed patients with chronic myeloid leukemia. Haematologica. 2010 Jun;95(6):914-21. doi: 10.3324/haematol.2009.016766. Epub 2009 Dec 16.

    PubMed 20015886

  • Deenik W, van der Holt B, Verhoef GE, Smit WM, Kersten MJ, Kluin-Nelemans HC, Verdonck LF, Ferrant A, Schattenberg AV, Janssen JJ, Sonneveld P, van Marwijk Kooy M, Wittebol S, Willemze R, Wijermans PW, Westveer PH, Beverloo HB, Valk P, Lowenberg B, Ossenkoppele GJ, Cornelissen JJ. Dose-finding study of imatinib in combination with intravenous cytarabine: feasibility in newly diagnosed patients with chronic myeloid leukemia. Blood. 2008 Mar 1;111(5):2581-8. doi: 10.1182/blood-2007-08-107482. Epub 2008 Jan 2.

    PubMed 18172005

  • Thielen N, van der Holt B, Cornelissen JJ, Verhoef GE, Gussinklo T, Biemond BJ, Daenen SM, Deenik W, van Marwijk Kooy R, Petersen E, Smit WM, Valk PJ, Ossenkoppele GJ, Janssen JJ. Imatinib discontinuation in chronic phase myeloid leukaemia patients in sustained complete molecular response: a randomised trial of the Dutch-Belgian Cooperative Trial for Haemato-Oncology (HOVON). Eur J Cancer. 2013 Oct;49(15):3242-6. doi: 10.1016/j.ejca.2013.06.018. Epub 2013 Jul 19.

    PubMed 23876833

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing cytarabine and imatinib mesylate in people with Leukemia, run by Commissie Voor Klinisch Toegepast Onderzoek at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Netherlands, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity and treatment-related toxicity per dose level. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00028847, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2013.

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