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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Brief Summary

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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.

Detailed Description

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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

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Leukemia

Keywords

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chronic phase chronic myelogenous leukemia chronic myelogenous leukemia, BCR-ABL1 positive

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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cytarabine

Intervention Type DRUG

imatinib mesylate

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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J.J. Cornelissen, MD

Role: STUDY_CHAIR

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Locations

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AZ Sint-Jan

Bruges, , Belgium

Site Status

Institut Jules Bordet

Brussels, , Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status

U.Z. Gasthuisberg

Leuven, , Belgium

Site Status

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, , Belgium

Site Status

Meander Medisch Centrum

Amersfoort, , Netherlands

Site Status

Vrije Universiteit Medisch Centrum

Amsterdam, , Netherlands

Site Status

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, , Netherlands

Site Status

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status

University Medical Center Groningen

Groningen, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, , Netherlands

Site Status

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

HagaZiekenhuis - Locatie Leyenburg

The Hague, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Isala Klinieken - locatie Sophia

Zwolle, , Netherlands

Site Status

Countries

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Belgium Netherlands

References

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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.

Reference Type RESULT

PMID: 20015886 (View on PubMed)

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.

Reference Type RESULT

PMID: 18172005 (View on PubMed)

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.

Reference Type DERIVED

PMID: 23876833 (View on PubMed)