NCT00349518

Brief Summary

The purpose of this study is to further assess the safety of dasatinib in imatinib intolerant or resistant patients with chronic phase chronic myeloid leukemia, advanced phase chronic myeloid leukemia or Philadelphia chromosome positive acute lymphoblastic leukemia. The efficacy of the drug in this kind of patients will also further be documented.

Trial Health

45
At Risk

Trial Health Score

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

Geographic Reach
6 countries

20 active sites

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 7, 2006

Completed
5 months until next milestone

Study Start

First participant enrolled

December 1, 2006

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Last Updated

February 17, 2016

Status Verified

April 1, 2011

Enrollment Period

1 month

First QC Date

July 6, 2006

Last Update Submit

February 16, 2016

Conditions

Chronic Myeloid LeukemiaAcute Lymphoblastic Leukemia

Keywords

Chronic and Advanced Phase CML andPhiladelphia Chromosome Positive ALL with imatinib intolerance or resistance

Outcome Measures

Primary Outcomes (1)

  • Incidence and severity of drug-related adverse events.

Secondary Outcomes (3)

  • Chronic Phase CML: Cytogenetic and Hematologic Response

  • Advanced Phase CML and Philadelphia positive ALL: Hematologic Response

  • Time to and duration of Cytogenetic and Hematologic Response

Interventions

DasatinibDRUG

Eligibility Criteria

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

You may qualify if:

  • Males and females, 18 or older
  • CP or AD CML or Ph+ ALL
  • Intolerant of resistant to imatinib
  • ECOG PS 0-2 (CP CML)
  • ECOG PS 0-3 (AD CML and Ph+ ALL)
  • Adequate hepatic and renal function

You may not qualify if:

  • Pregnant or breastfeeding females
  • History of significant cardiac disease
  • History of significant bleeding disorder (not CML)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Local Institution

Budapest, Hungary

Location

Local Institution

Bologna, Italy

Location

Local Institution

Orbassano (To), Italy

Location

Local Institution

Roma, Italy

Location

Local Institution

Nijmegen, Netherlands

Location

Local Institution

Rotterdam, Netherlands

Location

Local Institution

Gdansk, Poland

Location

Local Institution

Katowice, Poland

Location

Local Institution

Krakow, Poland

Location

Local Instiution

Lodz, Poland

Location

Local Institution

Lublin, Poland

Location

Local Institution

Warsaw, Poland

Location

Local Institution

Moscow, Russia

Location

Local Institution

Saint Petersburg, Russia

Location

Local Institution

Cambridge, Cambridgeshire, United Kingdom

Location

Local Institution

Glasgow, Central, United Kingdom

Location

Local Institution

London, Greater London, United Kingdom

Location

Local Institution

Liverpool, Merseyside, United Kingdom

Location

Local Institution

Newcastle, Tyne and Wear, United Kingdom

Location

Local Institution

Birmingham, West Midlands, United Kingdom

Location

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL PositivePrecursor Cell Lymphoblastic Leukemia-LymphomaBronchiolitis Obliterans Syndrome

Interventions

Dasatinib

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsLeukemia, LymphoidLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host Disease

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 6, 2006

First Posted

July 7, 2006

Study Start

December 1, 2006

Primary Completion

January 1, 2007

Last Updated

February 17, 2016

Record last verified: 2011-04

Locations

RU(2)GB(6)NL(2)PL(6)HU(1)IT(3)