NCT00237120

Brief Summary

This study will assess the safety and efficacy of imatinib in newly enrolled previously untreated patients with chronic phase CML.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Nov 2002

Longer than P75 for phase_3

Status
completed

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

November 1, 2002

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 12, 2005

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

First QC Date

October 7, 2005

Last Update Submit

November 20, 2009

Conditions

Chronic Myelogenous Leukemia in Chronic Phase

Keywords

Chronic Myelogenous LeukemiaImatinibCML

Outcome Measures

Primary Outcomes (2)

  • 3 years overall survival

  • Duration of remaining in chronic phase

Secondary Outcomes (2)

  • Cytogenetic response and hematologyc response in every 3 or 6 months with 3 years treatment of Imatinib,

  • Adverse event

Interventions

ImatinibDRUG

Eligibility Criteria

Age15 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed as Chronic Myelogenous Leukemia in Chronic Phase
  • Previously untreated with Interferon-alpha
  • Performance status is normal or capable of only limited self-care

You may not qualify if:

  • Patients who are pregnant or possibly pregnant
  • Significant hepatic diseases
  • Chronic Myelogenous Leukemia in advanced phase

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Leukemia, Myelogenous, Chronic, BCR-ABL Positive

Interventions

Imatinib Mesylate

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsMyeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidines

Study Officials

  • Novartis

    Novartis

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 7, 2005

First Posted

October 12, 2005

Study Start

November 1, 2002

Study Completion

June 1, 2007

Last Updated

November 23, 2009

Record last verified: 2009-11