NCT00028847

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1 leukemia

Geographic Reach
2 countries

16 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 4, 2002

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
Last Updated

September 17, 2013

Status Verified

August 1, 2011

First QC Date

January 4, 2002

Last Update Submit

September 16, 2013

Conditions

Leukemia

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Incidence of dose-limiting toxicity and treatment-related toxicity per dose level

Secondary Outcomes (5)

  • Rate and duration of molecular response

  • Rate and duration of complete hematological response

  • Rate and duration of complete cytogenetic response

  • Time to treatment failure

  • Overall survival

Interventions

cytarabineDRUG
imatinib mesylateDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (16)

AZ Sint-Jan

Bruges, 8000, Belgium

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Clinique Universitaire De Mont-Godinne

Mont-Godinne Yvoir, 5530, Belgium

Location

Meander Medisch Centrum

Amersfoort, 3816 CP, Netherlands

Location

Vrije Universiteit Medisch Centrum

Amsterdam, 10P 1HV, Netherlands

Location

Academisch Medisch Centrum at University of Amsterdam

Amsterdam, 1105 AZ, Netherlands

Location

Medisch Spectrum Twente

Enschede, 7500 KA, Netherlands

Location

University Medical Center Groningen

Groningen, 9713 EZ, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 RC, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, 6500 HB, Netherlands

Location

Daniel Den Hoed Cancer Center at Erasmus Medical Center

Rotterdam, 3008 AE, Netherlands

Location

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

Location

University Medical Center Utrecht

Utrecht, 3584 CX, Netherlands

Location

Isala Klinieken - locatie Sophia

Zwolle, 8000 GK, Netherlands

Location

Related Publications (3)

  • 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.

    PMID: 20015886RESULT

  • 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.

    PMID: 18172005RESULT

  • 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.

    PMID: 23876833DERIVED

MeSH Terms

Conditions

LeukemiaLeukemia, Myeloid, Chronic-PhaseLeukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

CytarabineImatinib Mesylate

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidMyeloproliferative DisordersBone Marrow DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

CytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsArabinonucleosidesNucleosidesNucleic Acids, Nucleotides, and NucleosidesBenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazines

Study Officials

  • J.J. Cornelissen, MD

    Daniel Den Hoed Cancer Center at Erasmus Medical Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 4, 2002

First Posted

January 27, 2003

Study Start

April 1, 2001

Last Updated

September 17, 2013

Record last verified: 2011-08

Locations

BE(5)NL(11)